PRACTICAL GOOD LABORATORY

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 1

PURPOSE: This document describes the Good Laboratory Practices to be followed to obtain reliable and reproducible results meeting regulatory standards with effective usage of time, manpower and resources. SCOPE: Applicable to all activities to be performed in the Quality Control Laboratory. RESPONSIBILITY: Laboratory Assistant / Analyst / Microbiologist : The Laboratory Assistant / Analyst / Microbiologist is responsible for, 

Execution of the procedure related to Good Laboratory Practices as specified in this QCP.

Section Head : The Section Head is responsible for, 

Ensuring that, the procedure related to Good Laboratory Practices is followed as specified in this QCP.

Head Quality Control : The Head Quality Control is responsible for, 

Ensuring that, the procedure related to Good Laboratory Practices is followed as specified in this QCP.

Laboratory QA : The Laboratory QA is responsible for, 

Monitoring that, the procedure related to Good Laboratory Practices is followed as specified in this QCP.

Unit Quality Assurance Head : The Unit Quality Assurance Head is responsible for, Monitoring that, the procedure related to Good Laboratory Practices is followed as specified in this QCP.

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 2

DEFINITION: Good Laboratory Practices (GLP) : Good Laboratory Practices embody a set of principles that provide a framework within which laboratory studies (activities) are planned, performed, monitored, recorded, reported and archived. GLP helps to assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessment. Raw Data : A raw data in laboratory refers to the filled work sheet, test data sheet (bounded or computer generated) or analysis sheet, records, memorandum, hand written notes, photographs, electronic data, drawings, record printouts from instrument / equipment software such as chromatograms, spectra, histograms etc., charts, dictated observations or recorded data from automated equipments. The raw data also includes result of environmental monitoring, calibration and information from Light Emitting Diode (LED) display of any equipment.

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

Section: Quality Control Page. NO. 3

CONTENTS Sr. No. 1.0

Quality Management

2.0

General

6

3.0

Premises and Utilities

9

4.0

Personnel

13

5.0

Training

6.0

Instruments / Equipments / Accessories

Particulars

Page No. 4

15 15

 Qualification :

Calibration and Maintenance

 Mean Kinetic temperature 23

7.0

Desiccant replacement and regeneration

8.0

Validation / Verification of Analytical Methods

9.0

Forced Degradation Study

10.0

Method Transfer

11.0

Sampling

26

12.0

Testing, Reporting and Certification of analysis

27

13.0

Retention of Samples (Reserve Samples / Control Samples)

30

14.0

Stability Studies

31

15.0

Photostability Study

32

16.0

Walk-in Chambers / Incubators

32

17.0

Chemicals, Reagents, Glassware and Analytical Standards

33

18.0

Documentation

35

19.0

Change Control

20.0

Non-Conformance

21.0

 Out-Of-Specification (00S) / Out-Of-Trend (00T) : Analytical Incidences :• Deviations :. Excursion in temperature and humidity (incase of Walk-In chambers / Incubators) Contract Laboratory Analysis

40

22.0

Self-Inspection (Internal Audits)

41

23.0

Complaints Handling

41

25 25 26

37 37

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

Section: Quality Control Page. NO. 4

PROCEDURE: 1.0

Quality Management :

1.1

The attainment of quality objectives, product quality (purity), efficacy and safety is the responsibility of senior management but requires the participation and commitment of staff which is vital.

1.2

There must be comprehensive and effectively implemented Quality Control systems which should be fully documented and their effectiveness should be monitored.

1.3

Quality Control System should be adequately resourced with competent personnel and proper premises, instrument / equipment and facilities to ensure that Quality Control functioning is effective in meeting the requirements.

1.4

Written job responsibilities of Quality Control personnel should be laid and followed strictly. The structure of the organization which is fundamental to the satisfactory operation of Quality Control should be appropriately defined including the hierarchies as per the functions.

1.5

The Quality Control department should be independent from Production department and Warehouse. The Quality Control department should be under the authority of the Quality Control Head who has appropriate qualifications and experience and reports directly to the top Quality management.

1.6

Quality Control should not be confined only to Laboratory operations, but should be effectively involved in decisions, which may concern the Quality of the products.

1.7 Quality Control Personnel should have access to Production and Warehouse areas for sampling and investigation as appropriate.

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 5

1.8

The Quality Control should have Quality Objective which includes : ' To ensure that all the products manufactured in the company are analysed as per their specifications, leading to meet the desired quality standards of marketing authorisation such that the delivered products will fit for their intended use and will help in maintaining and improving patient's health. Products should not place patients at risk due to inadequate safety, quality or efficacy.  To follow concept of continuous improvement and make best use of management resources in all quality matters.  To comply with all applicable laws and regulations.  To ensure all-round development of personnel through adequate training.  To create suitable environment for everyone to participate in quality improvement.  To ensure that all activities carried out are safe for personnel who come in contact with work.

1.9

Quality Control should meet the Quality Policy of organization which states : The Company is committed to ensure that every product it manufactures and distributes, consistently meets with present standards of Quality, Purity, Efficacy and Safety. Quality is collective responsibility. Excellence in products, processes and system is to lie achieved through the team efforts of trained personnel of the company. Implementation of the quality policy is done through quality systems based on current Good Manufacturing Practices in conformity with National and International Standards.

1.10

Pharmacopoeia and its Supplements or Addendums, Reference Standards, Working Standards, Reference spectra, other Reference material and technical books etc. as required, should be available in Quality Control Laboratory.

1.11 Quality Control is responsible for fulfilling the regulatory requirements for product registration.

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Good Documentation Practices Title

2.0

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 6

General :

2.1

GLP / GMP concerns all people who work in areas where it applies, whether they are managers, supervisors or staff. It also affects those 'indirectly' involved, in activities such as maintenance, cleaning, record keeping and in 'support' areas such as the quality, engineering and personnel departments etc. Although staff working - in GLP/GMP environment is carrying out different tasks using different skills, there are some basic rules which can be generally applied. Basic Rules to be followed are as follows :  Make sure to have the correct written instructions before starting a task.  Do not carry out a task for which you have not been trained or in which you do not feel competent.  Always follow instructions precisely. Do not cut corners. If in doubt, ask.  Define in advance what we are going to do.  Check that we have done and what we should have done.  Keep records of information, results and actions taken. Make clear accurate records of what was done and the checks carried out.  Check that the instruments / equipments used are clean, calibrated and correct ones as per procedure.  Always be on guard for labeling errors,  Labels should always be held securely and not left lying around,  Always, notify if labels are seen either detached or appear to be incorrect or are in wrong place,  Report any labels that are damaged or dirty,  Never remove a label which has been incorrectly applied and never stick a new label over an old one of the same type. If label is incorrectly affixed, strike it off, sign and paste new correct label adjacent to it,  Ensure that printed labels used are legible; if not then replace the same. The labels with poor legibility should be "X" marked with marker pen and discarded by tearing wherever possible. Incase of Status labels, refer QCP 21.  Keep everything clean and tidy.  Investigate problems. Always be on the look out for mistakes, defects and unusual events. Report them immediately.

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Good Documentation Practices Title

2.2

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 7

Quality Control Laboratory should be clean and the workbenches kept tidy in accordance with written cleaning schedules and whenever it is required. The activity of cleaning / disinfection should be recorded in the format. Refer Annexure QCP 01/A1.

2.3

The cleaning and disinfection of sterility and microbiological testing areas should be regular and according to written schedules and procedures. Refer MM 02.

2.4

The cleaning of Raw Material, Packaging Material, Finished Product and Stability samples storage compartment is to be done by using vacuum cleaner (if required) followed by cleaning with soft lint free duster. During cleaning avoid any possible cross contamination of the samples. Carry out cleaning fortnightly or earlier as and when required.

2.5 Clean the Glassware drying oven, Refrigerator, Deep freezer, Water bath of the instruments / equipments like Dissolution tester, Disintegration testers, Sonicators etc., used in the Quality Control Laboratory as per the procedure and frequency specified in the respective operating procedure or General Analytical Method. Maintain the record for the cleaning of above, using the format specified in Annexure QCP 01/A2. The responsible person should perform the cleaning activity. The second person responsible to cross verify the cleaning activity done should confirm the activity performed. He / she should tick mark in the log and should sign the same as checked by. For cleaning of Dissolution tester, refer Annexure QCP 01/A3. 2.6 Every time during usage of the dissolution tester, the temperature of the individual vessel (bowl) is to be recorded initially and immediately after the withdrawal of aliquot, as per respective equipment operating procedure. This is to be recorded in the individual test data sheet or as per Annexure QCP 01/A4. If the temperature is monitored by the software and print of the temperature recorded is available, the same can be used directly

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 8

2.7

To help the investigation of 00S / Error (if any) observed during dissolution testing, the weight of the individual Tablet / Capsule / unit dose (g) to be taken and to be recorded. Also individual tablet / capsule is to be monitored for opening pattern and observation of the same is to be recorded at the different time intervals (at least three intervals) depending on total dissolution time. In case of single time point dissolution like 30 minutes, 45 minutes, 60 minutes, monitoring to be done at every 10 minutes, 15 minutes, and 20 minutes respectively. In case of dissolution with profiling, the monitoring can be done during individual interval. If residue is found in any vessels, same should also be recorded. Record the observations in the individual test data sheet or as per Annexure QCP 01/A5.

2.8

Clean the workbenches after completion of work or at the end of the day whichever is earlier and keep the respective specification, GAM's, SOP's etc. used, back at the designated place.

2.9

General and specific written down instructions for safety should be circulated to each staff member and the instructions should be revised periodically as appropriate (e.g. poster displays, audio-visual material and by seminars/conferences).

2.10

While closing the Quality Control laboratory, ensure that all water taps, instruments (which are not running), equipments, computers are switched 'OFF'. Put off the lights, AC's and inform the Engineering department to put off the AHU's (wherever required) and close the department.

2.11

The laboratory main door keys should be submitted to Security department along with filled laboratory closedown checklist. Refer QCP 02.

2.12 Individual laboratory should also prepare the schedule for Non routine validations e.g. Glassware cleaning validation, sampling accessories cleaning validation, temperature distribution study for ovens, sampling kit cleaning validation, sampling room cleaning validation, dissolution accessories cleaning validation (Bowl, paddle, canullas etc), etc. Prepare the non-routine validation schedule; refer Annexure QCP 01/A6.

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 9

3.0

Premises and Utilities :

3.1

Quality Control Laboratories should be separated from Production areas and Warehouse. Independence of Quality Control from Production is considered fundamental to the satisfactory operation of Quality Control. Laboratory for in-process control can be located in Production areas, provided the operations of the production process do not adversely affect the accuracy of the laboratory measurements and the laboratory and its operations do not adversely affect the production process.

3.2

Premises must be built and maintained to suit the operations being carried out. Separate areas should be provided wherever required e.g. physico-chemical, microbiological, radio-isotope analysis etc.

3.3

The layout and design must aim to minimize the risk of errors, hazards and permit effective cleaning, operation and maintenance. The work flow (material and personnel), utilization and hazards of operation should be considered for defining area, e.g. wet area, dry area, area to handle hazardous chemicals, heating operations, washing / cleaning operations etc. should be adequately segregated for effective and safe functioning.

3.4

Separate instrument room with adequate area may be provided for sensitive and sophisticated instruments, to protect from vibration, electrical interference etc. and to control adequate temperature and humidity as required for analysis.

3.5

The laboratories should be designed, constructed and maintained so as to prevent entry of insects and rodents besides cross contamination. Following should be considered while designing the laboratory :  Interior surface (walls, floor, and ceilings) should be smooth and free from cracks, and permit easy cleaning and disinfection.  Adequate provision should be made not only for space and equipment for carrying out necessary test but also for utilities like water, electrical power and gas.  Air ventilation system should ensure dust free environment. Tabletops should be constructed with acid, alkali, and solvent resistant material and should be smooth and free from crevices as far as possible.

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 10

3.6

Quality Control Laboratories should be designed in such a way that sufficient space is given to avoid mix-ups and cross-contamination. The design of the Laboratory should take into account the suitability of construction materials and ventilation.

3.7

The workbench used for preparation of solution should be clean and clutter free. Adequate segregation should be provided between analysts working on same bench adjacent to each other. A separator / partition can be provided to segregate work area of analyst. Whenever a analyst is analyzing different materials / products simultaneously, separator is to be used to segregate the individual materials / products preparation. This is required to avoid contamination which could occur if segregation is not adequate.

3.8

There should be adequate and suitable storage space for samples, standards, laboratory reagents, apparatus, accessories and records.

3.9

Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate. These systems should be designed and constructed to minimize risks of contamination, cross-contamination and hazards and should include equipment for control of air, pressure, microbial load (if relevant), dust, humidity and temperature, as appropriate.

3.10

Separate air handling units should be provided for physico-chemical, microbiological and radio-isotope testing areas as required.

3.11

When there is a requirement for microbiological control, the manufacturing environment should be controlled for microbiological contaminants.

3.12

Appropriate measures should be established and implemented to prevent cross-contamination from personnel, materials etc. moving from one dedicated area to another.

3.13 Dedicated area should also be considered when material of an infectious nature or high pharmacological activity or toxicity is involved (e.g. certain cytotoxic anticancer agents etc.). Validated deactivation and / or cleaning procedures are to be established and maintained for such materials.

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 11

3.14

Adequate lighting should be provided in all areas to facilitate cleaning, maintenance and proper operations.

3.15

Laboratories should be provided with regular supply of water of appropriate quality for cleaning and testing purpose. For analytical preparations wherever water is to be used, use 'Purified water'. For chromatographic analysis like HPLC, GC, UPLC, IC etc. use ultra pure water.

3.16

Whenever the water purification system of the laboratory is under maintenance, alternatively purified water used in the Production department to be used, whereas for chromatographic preparations, commercially available HPLC grade water to be used. For collection of purified water from Production department, follow the procedure specified below : Every day, collect fresh water and store the same in suitable container in the laboratory. During collection, drain the water from user point for sufficient time. Before collecting water into the container, rinse the container twice and discard the washings. Wipe the outer surface of the filled container and label it. Refer Annexure QCP 01/A7. Alternatively a separate purified water line can be provided in the laboratory from the water purification system of unit catering water to different Production departments. At the end of the day, drain the unused water completely and keep the container dry.

3.17

The utilities such as electricity, compressed air, vacuum required for the functioning of laboratory should be adequate.

3.18

Suitable drains are to be provided for the laboratory; drains should be of adequate size and should be provided with an air break or a suitable device to prevent back-siphonage, where appropriate. The cleaning and sanitation of washing area and drainage points should be done as per procedure specified in CQA-191.

3.19 For the areas / equipments e.g. Ovens, Reserve Sample room, Refrigerators, Deep freezers, Stability Walk-in chambers / Incubators etc. where the temperature / humidity are controlled and expected to be within specified range, the temperature and humidity distribution study should be done as per procedure specified in QCP 63

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 12

3.20

When wet / dry bulb thermometer is• used, temperature and humidity of the different areas of Laboratory like Instrument room, Titration room, Reserve sample room, Sampling room should be maintained as per requirement and should be recorded twice a day. Wherever the digital thermohygrometer having the facility to record minimum and maximum temperature / humidity is used, record the observed temperature and humidity once a day along with the minimum and maximum value. Temperature and humidity record can also be monitored using electronic device like sensors, Building Management System (BMS) etc.

3.21

Maintain temperature and humidity record as per Annexure QCP 01/A8 or Annexure QCP 01/A9, as applicable. Record the temperature of refrigerator, freezer and cooling incubator as per Annexure QCP 01/A10.

3.22

Monitor the temperature and humidity record for the automated electronic device at periodic interval as specified in respective SOP e.g. for Walk-in chamber / Incubator record the temperature and humidity as per the procedure specified in QCP 72. For monitoring of the areas and equipments in microbiology laboratory, refer MM 03.

3.23

Proper access control should be incorporated to guard the area where restricted entry is necessary. The area should be labeled appropriately as per operation for better control.

3.24

Adequate storage area / facility with lock and key should be provided wherever protection is necessary to avoid misuse or hazard like poisonous material, reserve sample, stability samples, laboratory standards, tapes / CD's of back up data etc. The archive should provide a suitable environment that will prevent modification, damage or deterioration and / or loss of the contents.

3.25

Laboratory should be provided with eye washer, water shower, first aid kit etc. for any emergency which may arise during operation. Similarly the required fire extinguisher should be available in the laboratory to extinguish any fire in case of emergency.

3.26 An emergency exit should be available (should be free from obstacles) at appropriate place for exit during emergency.

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

3.27

Section: Quality Control Page. NO. 13

Wherever control is necessary, adequate audio-visual alarm system should be provided to guide user to take necessary action during operation e.g. alarm for excursion of temperature / humidity in sampling area, reserve sample area, etc.

3.28 All samples to be periodically reviewed and expired samples if any are to be disposed off as per respective specification and procedure specified in QCP 09. 4.0

Personnel :

4.1

There should be adequate number of personnel qualified by appropriate education, training and / or experience to perform and supervise the tasks assigned. A laboratory should have a Head (Quality manager or technical manager) for carrying out all technical activities and for implementation of documented quality system.

4.2

Head of the laboratory must be of high professional standing with experience in drug analysis and laboratory management who is responsible for : 

  

Ensuring the control and maintenance of documents including the quality system as per the requirements of regulatory authorities which involves all raw data, SOP's, documentation exhibits, protocols, training charts, etc. Planning and organizing the audit of the quality system and initiation as well as follow up action of the corrective actions, if any; Investigation of technical complaints; Taking final responsibilities for recommending any regulatory action in the event of noncompliance of tested samples.

4.3 All personnel prior to employment should be medically examined and then periodically re-examined for medical fitness. The Head Quality Control should ensure that the personnel are medically fit to carry out the job.

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 14

4.4

Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of analysis. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the health condition could adversely affect the job function until the condition is corrected or qualified medical personnel determine that the persons inclusion would not jeopardize the safety or quality of function.

4.5

All employees should be instructed to report about their illness or abnormal health condition to their immediate supervisor so that appropriate action can be taken.

4.6

Hierarchy according to the job responsibilities and functions should be clearly defined. Refer section on Organogram.

4.7

The job responsibility should be assigned according to competency of the person and it should be timely revised for addition or deletion of responsibilities assigned previously.

4.8

The job responsibilities of the personnel engaged should be specified in writing and followed strictly. Refer section on Job responsibilities defined for various hierarchies as per Organogram.

4.9

Personnel should practice good sanitation and health habits. Refer QCP 02.

4.10

Smoking, eating, drinking, chewing or keeping plants, food, drinks and personal medicines and installation / removal of contact lenses should not be permitted in Laboratory areas, where they might adversely influence the product quality or may lead to accidents. Do not drink water available in laboratory.

4.11 Personnel should wear clean clothing (company uniform) suitable for activity with which they are involved and this clothing should be changed on daily basis or when appropriate. Personnel should strictly follow entry / exit and gowning procedures.

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Good Documentation Practices Title

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 15

4.12

While sampling and handling cytotoxic, materials, hormones, radioactive material, poisonous, carcinogenic materials etc., while handling hazardous chemicals and while performing sterility, microbiological analysis, endotoxin testing etc., procedure of change of clothing and use of personal protective equipments and safety appliances should be strictly followed. Personnel should avoid direct contact with material / product. Refer QCP 02.

4.13

Never handle any chemicals, raw materials, intermediate or finished, unpacked products with bare hands. Always use appropriate hand gloves while handling thesame.

4.14

All personnel should follow the time schedule with respect to shift and should be punctual in attendance.

5.0

Training :

5.1

Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GMP as it relates to the employee's functions. GLP I GMP ultimately depends on people. The individual skills and understanding of people about their work can be developed by training. Training should be given on both the theory and practice of the work being undertaken in a particular area, as well as relevant 'on-job' (i.e. task-based) training.

5.2

Records of training must be maintained. Training should be periodically accessed. The detailed training procedure is described in CQA-31.

5.3

All staff, including new staff and existing staff should be given basic training on 'Good Laboratory Practices' during induction and at regular intervals subsequently. These training programs should be periodically updated. In addition during training, emphasis should be laid on regulatory requirements, health, safety and hygiene. Refer QCP 02.

6.0

Instruments / Equipments / Accessories :

6.1 The laboratory should be furnished with all types of instruments / equipments as may be necessary for carrying out the different activities within the laboratory.

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

Section: Quality Control Page. NO. 16

6.2 The analytical instruments should be housed in dust-free environment. Whenever required, conditions of temperature and humidity should be maintained and periodic checki on temperature and humidity should be made and recorded. 6.3 The instruments / equipments, instrument / equipment bench and surrounding areas should be kept clean, tidy and free from vibration at all times. 6.4 Instruments / equipments requiring calibration should be calibrated at regular intervals and records of such calibration or maintenance should be maintained. There should be written instructions in the form of Standard Operating Procedures for the operation. 6.5 Other equipments / accessories such as burettes, pipettes, volumetric flasks, weight boxes, thermometers etc. should be thoroughly checked for accuracy of calibration before acceptance for use. 6.6 All instruments / equipments, accessories like HPLC / GC columns, thermometers, etc., should be identified with a unique code number. Refer table for 'Numbering of Instrument / Equipments / Accessories' shown below: Sr. No. Item

Numbering procedure

Details

Remark If a particular location is having more than one unit, an alphabet may be applied as suffix to I/E as IA-001, IB-002 or EA-001, EB002 etc. where alphabet A, B...etc. differentiates the different units of same location.

1.

Instrument I - 001

Where I: instrument and 001: A unique serial number for particular instrument,

2.

Equipment E - 001

Where E: equipment and 001: A unique serial number for particular equipment. '

3.

HPLC and PGHR001/01, IC Column PGHS001/01, PGHA001/01, PGHM001/01 etc.

Where PG: Unit Identity e.g. Patalganga, H : HPLC and IC, R: Section identity e.g. R: Raw —………………………… material, S: Stability, A: ANDA, M: Method validation etc., 001: unique serial number and /01: version number of column.

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

GC Column

4.

PGGP001/01, PGGC001/01 etc.

Sr. Item No. 5. Electrode of Auto-titrator / pH meter etc. *Thermomet 6. er (Glass)

Numbering procedure PGE01/01

7.

Thermohygrometer

PGTH01/01

8.

Desiccator

PGDO1

9.

Paddle (Dissolution tester)

IA-005/01

10.

Mesh Sieves

PGMS01

PGTM01/01

Section: Quality Control Page. NO. 17

Where PG: Unit Identity e.g. Patalganga, G: Gas chromatography, P: type of — ................. column e.g. P: Pack column, C: capillary column, 001: A unique serial number and /01: version number of column.

Details Where PG: Unit Identity e.g. Patalganga, E: Electrode, 01:' A unique serial number and /01: version number of electrode.. Where PG: Unit Identity e.g. Patalganga, TM: Thermometer, 01: A unique serial number and /01: version number of thermometer. Where PG: Unit Identity e.g. Patalganga, TH: Thermo hygrometer, 01: A unique serial number and /01: version number of thermo hygrometer. Where PG: Unit Identity e.g. Patalganga, D: Desicqator, 01: A unique serial' number of desiccator. Where IA-005: Concern Instrument No. and /01 is the position no. of the paddle in a slot. Where PG: Unit Identity e.g. Patalganga, MS : Mesh Sieve, 01: A unique serial number.

Remark

Version No. of the thermometer / thermo hygrometer is to be revised to next only when the previous is replaced with the new one of same range and make.

Whenever existing desiccator is replaced with the new one, assign a new number for the same. Respective slot is also to be numbered with the same No. i.e. 01, 02,03 etc. Whenever existing mesh is replaced with a new one, assign the new mesh number for the same.

* Note : Incase the digital thermometer is used, assign the equipment number for the same.

6.7

Operating procedures (IOP's / EOP's) should be displayed near each instrument / equipment and should be followed whenever used.

6.8

All the instruments / equipments / accessories used in the laboratory having proper markings/scale on it, like thermometer, vernier caliper, measuring scale etc. are to be checked for the legibility of the markings, before every usage. Also in case of digital equipments / accessories e.g. digital flow meter, digital burettes etc., legibility of the digits displayed to be ensured before usage. If any of the same is found with poor legibility, rectify

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Good Documentation Practices Title

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Section: Quality Control Page. NO. 18

the defect / discontinue the same from usage. 6.9 All such instruments / equipments / accessories should be verified for the readability by in-house / outside testing agency during every calibration. The observations should be recorded and documented in the calibration certificate. Users on receipt of certificate should verify the check performed.

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

Section: Quality Control Page. NO. 19

6.10 While performing analysis on instruments / equipments, display the 'Analysis Status' indicating details of ongoing analysis. Refer table below. Sr. No.

Instrument Equipment name

I

1

HPLC / IC

2

GC

3

Dissolution

4

Instruments / Instrument / Equipment No., Product name, Batch No. / A.R. No., Test, Sign and Date. Equipments

Details on status display

Annexure Reference Number

Instrument No Product name, Batch No. / A.R. No., Mobile phase, Column No., Test, Sign QCP01/A11 and Date. Instrument No., Product name, Batch No. / A.R. No., Carrier gas, Column No., Test, Sign QCP01/Al2 and Date. Equipment No., Product name, Batch No. / A.R. No., Medium, RPM, Test, Sign and Date.

QCP01/A13

QCP01/A14

6.11

List of 'Authorized Users' for all major instruments / equipments should be displayed as per Annexure QCP 01/A15.

6.12

Usage log should be maintained for usage record of major instruments / equipments; Use format 'Instrument usage log' as per Annexure QCP 01/A16 for HPLC / IC and GC. Use format as per Annexure QCP 01/A17 for instruments like Coulometer, KF, pH meter, Conductivity meter and Autotitrator. Use format as per Annexure QCP 01/A18 for all other major instruments / equipments.

6.13

Individual column usage log for HPLC / IC and GC columns should be maintained. Refer Annexure QCP 01/A19 and Annexure QCP 01/A20 respectively. Document the relevant details. Based on the system suitability parameters achieved and comparison with initial value, document remark for performance as "column performance satisfactory / not satisfactory". If it is not satisfactory, investigate the cause and take appropriate action.

6.14

Individual electrode usage logs must be maintained. Refer Annexure QCP 01/A21. Maintenance of electrode should be done as per the procedure given in respective instrument operating procedure. 6.15 Alternatively usage log can be maintained by using electronic software.

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6.16

Temperature and / or humidity of stability walk-in chambers / incubators, refrigerators etc. should be maintained as per requirement and data should be recorded as per the written procedure.

6.17

Whenever instruments / equipments are in use for overnight it must be indicated with proper status label and same should be indicated in department closedown checklist. Refer QCP 02.

6.18

All the desiccators used in the laboratory should contain sufficient quantity of suitable desiccant. The desiccant should be replaced fortnightly or when desiccant losses its effectiveness (Colour changes from blue to colourless or pink), whichever is earlier. Update the label of the desiccators; also maintain the record of desiccant replacement. Refer Annexure QCP 01/A22 and Annexure QCP 01/A23 respectively.

X6.19

6.20

If any instrument / equipment / component / accessory is not qualified or calibrated as not to be used or does not meet calibration or under maintenance, it should be made inaccessible or inactive or labeled as per the procedure specified in QCP 23 such that its misuse can be avoided. e.g. if a dissolution apparatus has facility to perform testing of 12 dosage units but is qualified and calibrated only for 6 dosage units, the facility of other 6 units which are not qualified or calibrated should be made inactive to avoid use of such units by users. Instrument / equipment should be maintained in appropriate surroundings to support proper functioning, e.g. •Chromatographic instruments having oven / thermostat should be maintained with constant surrounding temperature of less than ambient condition to avoid drift in retention time during analysis, walk-in chambers / incubators should be placed in area having temperature control otherwise it may impact on thermal controlling system of machine.

6.21 Water from water bath of instrument / equipment (e.g. Dissolution, DT, Sonicators, etc.) should be replaced as per the procedure specified in respective operating procedure or when the water gets turbid, whichever is earlier. After replacement of water from the water bath, update the status on the label; refer Annexure QCP 01/A24. When instrument / equipment is not in use for longer period (e.g. breakdown), water should be removed and the instrument / equipment kept dry.

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Section: Quality Control Page. NO. 21

6.22 Incase of analytical balance, after completion of weighing, the balance print must be stamped with a black ink stamp with details as given below Bal. No. : _________________ Test : ____________________ Wt. of : ___________________ A.R. No. : _________________ Sign : _________ Date : ____

6.23 Whenever the balance is linked to controlled software and the weighing information is transferred automatically to the software, in such case above mentioned stamp is not applicable. The information specified on the stamp can be obtained as preprinted information on the report printed through software. 6.24

Small instruments printouts like weight printout attached to the reports to be signed in such a way that part of the signature is on the paper on which the printout is stapled. For attaching the weight prints to the report refer procedure specified in QCP 07.

6.25

Work involving the evolution of harmful and obnoxious vapours should be carried out in a fume cupboard. The exhaust system of the fume cupboard should be checked frequently to ensure that it is in order. There should be a water drainage system inside the fume cupboard and should be checked frequently to ensure that there is no water clogging and it is in order.

6.26

At the end of day's operation or after use, instrument / equipment should be cleaned and switched off and kept covered wherever possible.

6.27

Computerized systems :  Computer systems are used in the Laboratory for various purposes like controlling instruments, preparation of documents, preparation of labels etc.  Computerized systems with application software for instrument / equipment should be qualified and validated. Refer QCP 50 and QCP 73. Computerized system should have sufficient controls to prevent unauthorized access or changes to data. Refer QCP 68.

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

Written procedure should be available for each operation of computerized system used for application software of instrument / equipment, e.g. for detail procedure of instrument / equipment refer 10P / EOP, for user management control refer UMCS, for data operating refer DOP etc.  For documentation purpose, use suitable software like MS Word, MS Excel etc. The major documents prepared like specifications, 10P / EOP etc. using the MS Word, MS Excel should have the password protection. The excel sheet used for calculation purpose should be validated and used.  While preparing / updating any document, save the entered data periodically, assign a suitable file and path name to the document prepared.  Maintain a dedicated folder for the individual document; folder should be named with the document number along with its version number for easy identification and retrieval. Respective folder should contain all concerned documents related to that version, e.g. core document of respective version, all related annexures, review sheet for that version etc.  Along with the review of printed data, reviewer should verify the electronic copy randomly to ensure correctness of data. The printed copy and electronic copy should be same in all regards.  Where critical data are being entered manually, there should be an additional check on the accuracy of the entry which can be done by second operator or by the system itself.  Changes to the computerized system should be made according to a change procedure and should be authorized, documented and tested.  If the system breakdowns would result in the permanent loss of the records, a back-up system should be provided. A means of ensuring data protection should be established for all computerized systems.  Software should be reviewed and necessary security controls to be applied. For detail procedure, refer QCP 68. 6.27.1 The detail procedure for procurement, usage and qualification of the workstation is as described in QCP 50.

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6.28 6.28.1

Section: Quality Control Page. NO. 23

Qualification : All new major instruments / equipments should be qualified before use and relevant operating procedures should be prepared. Qualification is usually carried out by conducting the following activities, individually or combined.    

Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)

6.28.2 Re-qualification is necessary in following circumstances  Modification / up-gradation of instrument / equipment.  Shifting of instruments / equipments from one place to other. Qualification in such case is necessary for instrument / equipments where shifting may impact alignment / functioning.  Replacement of major component of instrument / equipment. 6.28.3 6.29

The detail procedure for Qualification of instruments / equipments is as described in QCP 73.

Calibration and Maintenance

6.29.1

Each instrument / equipment should have calibration status tag. Refer QCP 23 Calibration status should be ensured for validity prior to use.

6.29.2

All instruments / equipments should be calibrated as per defined schedule and as per procedure. The standard operating procedure for calibration should be available. The records of calibration should be maintained. The standards used for calibration should have traceability with national or international standards (wherever applicable).

6.29.3 Emphasis should. be given on planned preventive maintenance to minimize the potential for breakdown and same should be recorded in instrument / equipment history log. The detailed procedure for calibration and maintenance for instruments / equipments is as described in QCP 23.

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6.29.4

The maintenance of equipments for services like electricity, gas, water, steam and compressed gas should be handled by competent person.

6.29.5

If any Instrument / Equipment shows malfunctioning, impact assessment on previous analysis should be done. Refer QCP 23.

6.30

Mean Kinetic temperature :

6.30.1

Mean kinetic temperature is to be determined for Walk -in chambers, incubators and areas like reserve sample room. Calculate the Mean kinetic temperature as per procedure specified in QCP 72 for Walk-in chamber / Incubator and QCP 08 for Reserve sample storage areas.

7.0

Desiccant replacement and regeneration :

7.1

Wherever the control on absorption of moisture is required during operation or measurement, sufficient quantity of self indicative silica gel or molecular sieve to be used, e.g. analytical balances where exposure of hygroscopic material during weighing will result absorption of moisture and in-appropriate weighing amount.

7.2

In Quality Control department the instruments / areas like Analytical Balance, Autotitrator, Karl Fischer Titrator, FTIR, UV Spectrophotometer, Atomic Absorption Spectrophotometer, Desiccators, Karl Fischer Coulometer, TOC manifold, Gas manifold, Volumetric solution bottle used for non aqueous titration e.g. 0.1 N Perchloric acid etc. needs use of desiccant and routine monitoring of replacement of the same.

7.3

Unless otherwise specified in concerned instrument / equipment operating procedure, replacement of desiccant to be done weekly or if desiccant gets deactivated, whichever is earlier. Record of the replacement of desiccant is to be maintained, refer Annexure QCP 01/A23. The responsible person should perform the desiccant replacement activity. The second person responsible to cross verify the desiccant replacement activity done should confirm the activity performed. He / she should tick mark in the log and should sign the same as checked by.

7.4 Before using any instrument / equipment, check the color of silica gel / rubin gel used as desiccant for the instrument and equipment.

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7.5

Also the desiccant used in the different desiccators is to be replaced fortnightly or if desiccant gets deactivated (Blue color faded to pink / colorless), whichever is earlier. Maintain the record of the replacement.

7.6

In case of desiccators, remove all the content from the desiccators and collect the entire desiccant from the same. Wipe the inside of the desiccators using the soft dry cloth. Collect the entire used desiccant and regenerate the same.

7.7

Replace the used desiccant with the new or regenerated desiccant.

7.8

Apply grease on the neck point of the -desiccator;-Keep-back-the contents and close the desiccator. Remove / wipe the label on the desiccators and write the date of replacement of the desiccant and due date for replacement of the desiccant. The person replacing the desiccant should sign the label.

7.9

Desiccant used in the Quality Control laboratory is to be re-generated as follows :

7.9.1

On the due date of replacement of desiccant / whenever the colour of the silica gel turns to pink / colorless from blue color or whenever the colour of the rubin gel turns to light pink from reddish pink colour, collect the deactivated desiccant from the instruments / desiccators and dry (regenerate). For regeneration keep the used desiccant in a petridish or in a suitable glass container and dry it in an oven at 105°C until it acquires uniform blue or reddish pink color (as applicable). Incase even after regeneration if the desiccant found not suitable for usage, discard the same as per procedure.

7.9.2

Allow the regenerated silica gel / rubin gel to attend the room temperature in a desiccator and then use wherever required / store the dry desiccant in an air tight container.

7.9.3 On the receipt of new desiccant, quality of desiccant to be monitored by visual check. The desiccant should appear activated e.g. silica gel received should be dark blue colored and not pink or colorless, molecular sieve received should not appear moistened, rubin gel received should be reddish pink. In case of the desiccant received is not suitable, consignment is to be rejected.

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7.9.4

Incase of the Gas Management System, replace the desiccant (e.g. Silica gel, molecular sieve etc.) as per procedure specified in QCP 64.

8.0

Validation / Verification of Analytical Methods :

8.1

The policy, intentions, and approach to validation, including analytical method, and persons responsible for design, review, approval and dobliffiefifitiOn Of each validation phase, shot-ild be -documented.

8.2

Non-compendial analytical _methods should be validated whereas compendial (Phamiacopoeial) methods need verification to check suitability of testing methods under actual conditions of use.

8.3

Validation / verification provide assurance of result reliability and reproducibility. Appropriate qualification of analytical instruments should be considered before starting validation of analytical methods.

8.4

A written protocol should be established that specifies how validation / verification will be conducted. The protocol should be reviewed, verified and approved by the designated authorities.

8.5

A validation / verification report should be prepared, summarizing the results obtained, and drawing the appropriate conclusions, including recommendation for changes if any, based on the study.

8.6

Any deviations or variations from the protocol if done should be documented with appropriate justification.

8.7

The detailed procedure of validation / verification is described in QCP 16. For validation / verification of bio assay methods, refer to MM 31.

9.0

Forced. Degradation Study :

9.1

Forced Degradation Study is carried out to identify the likely degradation products, which can establish degradation pathways, the intrinsic stability of the molecule and evaluate the stability indicating power of the analytical procedures used.

9.2 The Forced Degradation Study is applicable to Assay and Related Substances test performed for all drug substances and drug products.

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9.3

The detail procedure of Forced Degradation Study is described in QCP 28.

10.0

Method Transfer :

10.1

Analytical method should be transferred to laboratory staff successfully. The_ process_of___method_transfer provides _confidence to users and certifies them to perform analysis correctly and independently.

10.2

The detailed procedure of method transfer is described in QCP 32.

11.0

Sampling : Sampling is the process of abstraction of a representative portion of material or a group of units from a larger quantity of material or collection of units. Sampling is done in order to test a small portion and obtain information that can be used as a basis for action on the large quantity or collection of units or for monitoring the production process. Since the logic of sampling is that of generalising with the information obtained from a portion about the whole batch / consignment, a sample must accurately represent the batch / consignment that is being tested.

11.2

Sampling should be done in accordance with approved written procedure. The procedure should describe  The method of sampling  Equipments to be used  The quantity of sample to be withdrawn  Instruction / precautions to avoid sample contamination deterioration  Type and condition of sample container to be used  Identification of container sampled  Any special precautions to be taken  Storage condition  Instructions for cleaning and storage of sampling equipments The procedure for sampling of all input materials and products is as described in QCP 06. The procedure for sampling of water (i.e. Potable water, Purified water and Water for injection) and steam condensate (i.e. Boiler and Pure) is as described in QCP 74.

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11.3

Sampling staff should be trained for sampling activity and should have knowledge of the nature of the; samples to be handled and should refer respective specification for the same.

11.4

Sampled containers should be adequately labeled and should have information for traceability.

11.5

The procedure for identification, usage, cleaning, cleaning validation, storage and maintenance of sampling accessories used in the laboratory is described in QCP 30.

12.0

Testing, Reporting and Certification of analysis :

12.1

Testing should be conducted under the direct supervision of competent technical staff.

12.2

There should be written procedure for testing materials and products at different stages of manufacture, describing the methods and instruments / equipments to be used.

12.3

The samples of starting materials, packaging materials, intermediate products, bulk products and finished products should be tested before use.

12.4

All samples for analysis should be registered and numbered for easy retrieval of samples and records related to them. Refer QCP 07.

12.5

Incase of Raw Materials (API, Excipients and API starting materials) the identification tests needs to be performed on the individual sampled container prior to proceeding for composite sample preparation and analysis.

12.6 Testing should be done as per approved specification. The results obtained should be checked for compliance against specification. All calculations should be checked. The records of testing should be maintained. The procedure for receipt, registration of samples, testing, reporting and review of results, approval of cleaning aids, disinfectants and ancillary item is given in QCP 07.

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12.7

Microbiological testing should be done for water, raw materials, APIs, in-process samples, formulations, environmental monitoring and packaging materials as applicable.

12.8

While performing tests, instructions for use and storage of laboratory reagents, volumetric solutions, 'reference standards, culture media etc. should be followed. The instruments / equipments should be used within the permitted range and as per the written operating procedures.

12.9

In case of analysis of temperature sensitive materials stored at 2 - 8°C or in freezer (between -25°C to -10°C), follow the procedure as below,

12.9.1

Collect the sample from respective .storage area and allow the same to attain the ambient temperature before using i.e. weighing, pipetting etc.

12.9.2

Do not expose the sample to ambient temperature for longer duration i.e. for greater than 60 minutes.

12.9.3

During analysis close the sample container immediately after use and do not leave it opened. Preserve the sample container away from heat. Replace sample back to storage area immediately after sample preparation.

12.9.4 Prior to weighing the samples / standards, performing the dilutions, vial filling etc., the analyst should prepare the required labels on the label sheet (i.e. necessary details are mentioned on the labels). After individual sample / standard is weighed, dilution, vial filling, etc. is performed, affix the already prepared label on the glassware / vial, immediately. 12.10

All glassware in use should be labeled properly with the details as given below. Alternatively glassware can be labeled with glass marker pen where affixing of label is not possible e.g. HPLC glass vials. Name : A. R. No. : Test : Soln : Sign : Date :

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The test record should include name of material / product with dosage form wherever applicable, batch number, reference to the relevant specification and testing procedure, test results, including observations and calculations, date of testing, initials of persons performing testing, initials of persons verifying the testing and calculations, a clear statement of release or rejection (or other status decision) and dated signatures of the designated responsible persons.

12.12

Whenever in specification the measurement is specified as e.g. 5.0 g or 5.0 ml, the measurement is to be done accurately (i.e. 5.0 g to be weighed using Analytical balance and for 5.0 ml, 5 ml capacity pipette to be used). If the measurement is specified as e.g. 5 g or 5 ml, the measurement is to be done approximately (i.e. 5 g can be weighed using Precision balance and 5 ml can be measured using 5 ml or 10 ml capacity measuring cylinder).

12.13

Whenever in specification it is specified that, shake the prepared solution, then the same should be shook manually. If it is expected to be shook using mechanical shaker the same should be specified in respective specification clearly as e.g. "Shake the solution using mechanical shaker".

12.14

In case of the chromatographic analysis like HPLC, UPLC, IC etc. mobile phase prepared should be properly labeled. Refer Annexure QCP 01/A25. Label for 'Column / Syringe / Plunger' flushing as per Annexure QCP 01/A26. Label for 'Diluent / Buffer / Dissolution Medium' as per Annexure QCP 01/A27. For detail Good Chromatographic Practices, refer QCP 64.

12.15

No batch of material / product should be released for sale or supply prior to certification by a qualified person that it is in accordance with the requirement of relevant authorization.

12.16 After completion of analysis and review of data, glassware should be cleared from the workbench. Discard the contents from glassware and keep for washing.

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12.17

The disposal of balance analytical samples should be done carefully by following the safety precautions mentioned in respective specification or according to procedure specified in QCP 09. Hazardous / cytotoxic / carcinogenic / hormones / poisonous / radioactive material / Penicillin waste should be disposed off after de-activation wherever applicable as per respective written proceddres. For disposal of used media after microbiological analysis, refer MM 05.

12.18

Certificate of analysis should be prepared for required consignment. The procedure for preparation of Certificate of analysis is specified in QCP 18.

12.19

The certificate should list each test performed in accordance with specification, including the acceptance limits and results obtained.

13.0

Retention of Samples (Reserve Samples / Control Samples) :

13.1 Samples from each batch of starting material, packaging materials (printed / primary) and finished product should be retained. Finished products should be kept in their final packaging (market pack) and should be stored under the recommended conditions. 13.2

Samples of starting materials `[other than hazardous materials (Acid, alkali etc.,), volatile solvents, flavors, liquid raw materials and liquid excipients, gases, water and hygroscopic materials (Excipients) (e.g. Sodium Hydroxide)] should be retained after their release, for future reference.

13.3

The packaging and holding of reserve sample is for the purpose of potential failure evaluation of the quality of the batches and not for future stability testing purposes.

13.4 Retention samples of materials and products should be of a size sufficient to permit two full re-examinations and should be stored for an appropriate length of time. Refer QCP 08 for procedure for maintaining reserve sample.

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14.0

Section: Quality Control Page. NO. 32

Stability Studies :

14.1 Stability studies should be carried out to obtain evidence on how the quality of a drug substance or drug product varies with time under the influence of factors such as temperature, humidity and light and enables establishment of recommended storage conditions, retest periods or shelf life for drug substances or drug products. 14.2

The test procedures used in stability testing should be stability

14.3

A documented on-going testing program should be designed to

indicative. monitor

the stability of each drug substance / drug product and the results should be used to confirm appropriate storage conditions and retest / expiry dates. 14.4        14.5

market

The protocol for on-going program should include, but not limited to The number of batches per strength Relevant physical, chemical, microbiological test methods Reference to test methods Description of container closure system(s) Testing intervals (time points) Description of storage conditions Other applicable specific parameters to the product Stability samples should be stored in containers that simulate the

container e.g. if the API is marketed in bags within the fiber drums, stability samples can be packaged in bags of the same material and in miniature fiber drums.

14.6 Out of specification or significant atypical trends should be investigated. Product failures should be promptly reported to Unit Head, Regulatory affairs, R & D, Quality Assurance and Customer (if applicable) for necessary action. The possible impact on the batches distributed in the market should be considered. 14.7 A summary of data generated should be written and maintained. This summary should be subjected to periodic review. 14.8

Samples of drug product and drug substances should be subjected to

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stability studies as per the procedure described in QCP 15.

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15.0

Photostability Study :

15.1

Photostability is the ability of a molecule / drug substance / drug product to remain intact and unaffected wheneverexposed to the light source.

15.2

Photostability study (i.e. confirmatory study) is performed to identify precautionary measures need_ed in manufacturing_or in formulation of the drug product, and if light resistant packaging is needed. It provides the information necessary for handling, packaging and labeling of the respective drug substance / drug product. In this study the samples are exposed to the light providing an overall illumination of not less than 1.2 million LUX hours and an integrated near ultraviolet energy of not less than 200 watt hours / sq. meter (option II as per ICH guideline).

15.3

The Photostability study is applicable to all drug substances (API) and drug products (Formulations). The detail procedure of Photostability study is described in QCP 77.

16.0

Walk-in Chambers / Incubators:

16.1

The laboratory should be furnished with Walk — In Chambers / Incubators for storage of contents like analytical samples, standards, reagents, chemicals etc. Also, the reserve sample of API, Excipients, Finished products, Placebo etc.. which are required to be stored at specific temperature/ humidity conditions etc. can be stored in Walk — In Chambers / Incubators.

16.2

Walk — In Chambers / Incubators should have built in audio-visual alarm system to alert the user whenever the set conditions of Temperature / Humidity in the Walk-In Chamber / Incubator deviate from the acceptance criteria, so that necessary action can be initiated.

16.3

To avoid mixing of samples, Walk-in-chamber / Incubators should have dedicated racks / trays with proper labeling. List of all samples of individual type should be maintained along with the location chart for easy retrieval of the samples. Individual sample is to be properly labeled as per respective labeling procedure.

16.4

Temperature and / or humidity of stability walk-in chambers/ incubators, refrigerators etc. should be maintained as per procedure specified in QCP 72.

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17.0

Chemicals, Reagents, Glassware and Analytical Standards :

17.1

Special attention should be given to the quality of laboratory reagents, volumetric glassware and solutions, standards and culture media. Reagents and standards should be prepared and labeled as per written procedures. For Chromatographic analysis like HPLC and GC, always use chromatographic grade solvents and reagents.

17.2

All reagents and solutions in the laboratory should be properly identified with a label. Validity should be provided as appropriate for analytical reagents or standard solutions prepared and should be indicated on label together with specific storage conditions.

17.3

Adequate space with proper storage conditions in the laboratory should be provided for keeping reference and working standards and should be maintained by the Quality Control department.

17.4

The standards and solutions should be labeled with date of preparation, date of standardisation, validity, direction for use (wherever required), storage conditions and initials of person preparing the same. Soiled and disfigured labels of reagents and volumetric solutions should be replaced. Chemicals / reagents commercially purchased having soiled / disfigured label should not be accepted or used. Labels of empty reagent / chemical bottles should be defaced before disposal. Empty bottles of hazardous chemicals / acids should be rinsed with water before sending for disposal.

17.5

Storage and handling of chemicals and reagents should be done in a manner considering the physicochemical properties of these substances and the hazards involved in their use.

17.6

Incompatibility chart of chemicals should be displayed near to the chemicals storage area. Material safety data sheet should be maintained for hormones, cytotoxic, carcinogenic, poisonous, radioactive materials and other such hazardous chemicals.

17.7 All the solutions, solvents dispensed and solvent waste collected in vessel/beaker should be covered entirely with appropriate cover e.g. using aluminum foil / glass lid etc. to avoid the probable contamination as well as exposure of the solvent vapors in the laboratory.

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Section: Quality Control Page. NO. 36

17.8

Dispensed Karl Fischer reagent and methanol should be labeled as per Annexure QCP 01/A28 and QCP 01/A29 respectively. Assign validity of one week for the dispensed Karl Fischer reagent and methanol. Purified water from wash bottles used in the laboratory should be changed every day and should be labeled. Refer Annexure QCP 01/A7. Conductivity and pH of water used daily should be monitored and recorded. Refer Annexure. QCP 01/A30.

17.9

The system of receipt, preparation, standardization, usage and storage of Laboratory chemicals as well as reagents solutions, indicators solutions and volumetric solutions is described in QCP 03.

17.10

The procedure for maintenance, qualification, validity evaluation, storage and usage of laboratory reference standards is as described in QCP 14.

17.11

The glassware used for analysis should be of appropriate quality and capacity. Only Class A graduated glassware ,should be used unless validated. Certificate of calibration should be maintained. Graduated glassware should not be dried at high temperature (generally more than 60°C) which could alter volumetric graduation.

17.12

The glassware should be examined before use for cleanliness and damage; do not use cracked, chipped or any other defective glassware. The effectiveness of glassware cleaning should be periodically determined by performing validation studies as per written procedure. The procedure of usage, cleaning, drying, storage and maintenance is described in QCP 52.

17.13 In case of the different cleaning agents / disinfectant solutions prepared in the laboratory e.g. Teepol solution and Ortho-phosphoric acid solution prepared daily for the cleaning of glassware using the glassware washing machine, 'Benzol/Septol', 'Sansqad 40p', `Sansquad gsh' solution prepared for laboratory cleaning etc., preparation record of the same is to be maintained. Refer Annexure QCP 01/A31. For preparation of cleaning agents / disinfectant solutions refer CQA-193.

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

Section: Quality Control Page. NO. 37

18.0

Documentation :

18.1

Good documentation constitutes an essential part of the system. Clearly written documentation prevents errors from spoken communications.

18.2

Specifications, instructions, procedures and records must be free from errors and available in writing. Standard operating procedures should be available fot sampling, inspection and testing "of fa* rnatelialS, intermediates, bulk finished- products, finished products, packaging materials and whenever necessary, for monitoring environmental conditions.

18.3

Documents should be approved, signed and dated by appropriate and authorized persons. Strict adherence to documented procedures and specifications should be ensured.

18.4

Reproduced documents (such as authorized usage copy or uncontrolled copy) should be clear and legible. The reproduction of any documents from master documents must not allow any error to be introduced through the reproduction process. The authorized usage copy should be issued for regular use.

18.5

The content of the document like Title, Purpose, Scope, Procedure etc. should be clear, legible and concise.

18.6

Documents should be regularly reviewed and kept up-to-date. When a document is revised, systems should be operated to prevent inadvertent use of superseded documents. Master list of all documents should be maintained.

18.7

Documents should not be hand-written (except for the entry of data), these entries should be made in clear, legible, indelible handwriting. Sufficient space should be provided for the documentation of such entries.

18.8 Any correction to a record should be scored with a single line and new entry should be made alongside the original entry, signed and dated; the correction should permit the reading of the original information. Where appropriate, the reason for the correction should be recorded. There should be no overwriting and correction fluid/ eraser should not be used.

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Section: Quality Control Page. NO. 38

18.9

Records should be made or completed at the time each action is taken and in such a way that all significant activities are traceable. Documents should be preserved appropriately (product / material wise or A.R. No. wise) for easy retrieval and for appropriate time.

18.10

Wherever data are recorded by electronic data processing system, photographic or other means, procedure relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by.electronic data processing methods, only authorized persons should be able to access, enter or modify data in the computer and there should be a record of changes and deletions. Access should be restricted by password or other means and the result of entry of critical data should be independently checked. Such electronic data should be protected by back-up transfer on magnetic tape, microfilm, paper or other means. Data should be readily available throughout the period of retention. Backup restoration validation should be performed periodically as per written procedure.

18.11

Raw data on thermal paper might fade away with time; therefore, a photocopy of the thermal paper should also be retained in the archive.

18.12

Detailed procedure for preparation, review, updation, amendment, distribution, withdrawal and storage of documents related to Quality Control is described in QCP 34.

18.13 On receipt of certificates from outside location / organization (e.g. Working Standard Certificate, Approved External Party Calibration Certificate, Certificate Of Analysis of Raw material received from supplier etc.) the same should be reviewed and verified by the Quality Control. For review follow the procedure specified in concerned SOP. Person reviewed the certificate should affix a stamp as 'Verified By' in blue ink as shown below and should sign the same along with date .

VERIFIED BY "QC" Sign : _________________________________ Date :

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Title

Section: Quality Control Page. NO. 39

19.0

Change Control :

19.1

Change control system should be established to evaluate all changes that may affect product quality. Written procedure should provide for identification, documentation, appropriate review, and approval of changes.

19.2

The potential impact of the proposed changes should be evaluated. When implementing approved changes, measures should be taken to ensure that all documents affected by the change are revised.

19.3

Change control procedure should be applied to changes made to the existing operating system / equipment or process / procedure / document or any combination thereof. This procedure should be also applied to new operating system / equipment or process / procedure / document or any combination thereof. Every change should be identified, documented, reviewed and approved. Depending on types of change, concerned body should be addressed and approval should be taken.

19.4

Separate logs should be maintained for change control depending upon the type of change e.g. document and instrument / equipment or system as given in QCP 33.

20.0

Non-Conformance : For Quality Control operation, all non-conformances are classified and addressed as below : a) b) c) d) e)

Out-of-specification (00S), Out of Trend (00T), Analytical Incidences, Deviations, Excursion in temperature and humidity (incase of Walk-in chambers / incubators) The detail procedure for above mentioned non conformances is specified below. For schematic display of non-conformances in the laboratory refer Annexure QCP 01/A32.

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PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 40

20.1

Out-of-specification (005) / Out-of-Trend (00T) :

20.1.1

Any Out-of-specification (OOS) / Out-of-Trend (OOT) test results observed in laboratory should be investigated, evaluated and documented according to a defined procedure and should be reported to the relevant competent authorities.

20.1.2

The procedure should require analysis of the data, assessment of whether a significant problem exists, allocation of the tasks for corrective actions, and conclusions.

20.1.3

Any re-sampling and/or retesting after OOS / OOT results should be performed according to a documented procedure.

20.1.4

Detailed procedure for handling of OOS / OOT is described in QCP 47 for Chemical OOS / OOT, QCP 54 for Packaging material OOS, CQA-311 for microbiological test results OOS and CQA-324 for sterility test result OOS.

20.1.5

For establishing of trend limit based on laboratory test results and its routine monitoring, refer the procedure as specified in QCP 62.

20.2

Analytical Incidences :

20.2.1

All the analytical incidences that may occur during analysis, calibration, e.g. non-conformance observed (other than OOS or OOT test results) during the performance of a test procedure or identified during review should be investigated, evaluated and documented according to procedure.

20.2.2

The investigation is required to identify laboratory error s such as instrument malfunctioning, analyst error, method error, variation of results among replicate determinations, abnormal response or pattern of standard or sample, transcription error, system suitability failure or any kind of the error.

20.2.3

All incidences that need investigation to determine the root cause should be investigated.

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Section: Quality Control Page. NO. 41

20.2.4 All obvious errors can be acknowledged in the respective document itself with sign and date. For detail procedure of investigation, refer QCP 38. 20.2.5 Detailed procedure for handling of Analytical incidences is as described in QCP 38. 20.3 Deviations : 20.3.1 Deviation is departure from an approved written instructions or established standards. All the non-conformances (planned / unplanned) related to receipt, handling, storage, testing and release etc. which does have impact on quality of the product distributed in the market need to be considered as deviation. Following are the examples of deviation. e.g. a) Modification in the specified analytical method used for the routine analysis of an item / product. b) Stability study for a particular batch is skipped considering the earlier available sufficient data. c) Calibration not performed as per pre planned schedule. 20.3.2 Whenever a deviation occurs it should be informed to Quality Assurance, the same should be logged, investigated and documented. The detailed procedure for the same is as described in CQA-51. 20.3.3 Other laboratory non-conformances to be investigated and documented as per relevant procedure defined in SOP e.g. 00S / OOT / Analytical Incidences / Excursion in temperature and humidity (incase of Walk-in chambers / incubators) are as specified above. 20.4 Excursion in temperature and humidity (incase of Walk-in chambers / incubators) : 20.4.1 The non-conformances like excursion of Temperature / Humidity of the walk-in chambers / incubators (used for stability study), Incubators used for working / reference standards storage / Microbiological activities, Reserve / retention sample storage area etc. are to be investigated and documented with necessary corrective / preventive action.

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Title

20.4.2

21.2

21.3

Page. NO. 42

The detail procedure for excursion in temperature and humidity (incase of Walk-in chambers / incubators) is as described in QCP 72. 21.0

21.1

Section: Quality Control

Contract Laboratory Analysis :

Analysis of certain materials for specific tests that cannot be carried out at the site / incase of instrument / equipment breakdown or in case of urgencies, can be done at approved contract laboratories. The contract laboratories should be provided with the sample information and specification necessary to carry out the tests. The use of contract laboratories should be in conformity with the current Good Manufacturing Practices. Contract Laboratories should be evaluated / audited by contract giver and a list of approved contract Laboratories should be available in Laboratory. There should be a written and approved contract or agreement between contract giver and the contract acceptor that defines in detail the responsibilities, including the quality measures of each party.

21.4

The contract should permit the contract giver to audit the contract acceptor's facilities for compliance with GMP.

21.5

Where subcontracting is allowed, the contract acceptor should not pass to a third party any of the work entrusted to him under the contract without the contract giver's prior evaluation and approval of the arrangements.

21.6

Changes in the equipment, test methods, specifications, or other contractual requirements should not be made unless the contract giver is informed and approves the changes.

21.7 Contract analysis in case of products for regulated markets should be done in accordance with the Technical Agreement. The detail procedure for sending samples to contract laboratory for analysis is as described in QCP 76. The contract laboratory should be audited as per procedure specified in CQA-39.

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Title

22.1

Section: Quality Control Page. NO. 43

22.0 Self Inspection (Internal Audits) : In order to verify compliance with the Quality Control system, regular

internal audits should be conducted in accordance with an approved schedule. The audit should be done by designated competent persons appointed by the top-management other than the incharge of the laboratory. 22.2 Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. The agreed corrective action should be completed in a timely and effective manner. Detailed procedure is included in CQA-54.

23.1

23.0 Complaints Handling : All complaints and other information concerning potentially defective

products must be reviewed carefully according to written procedure. Refer CQA-37. 23.2

Records of complaints should be retained in order to evaluate trends,

frequencies and severity to take additional and appropriate corrective action wherever applicable. 23.3

As a part of investigation, samples of product complaints should be

retested (whenever required). 23.4 Competent person of the concerned department, Lab QA and Quality Assurance should investigate the product complaint and observations found should be documented.

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Section: Quality Control Page. NO. 44

ABBREVIATIONS:

QCP GAM MM A.R. No. HPLC APIs SOP 00S EOP AHU GC CQA DT CD R&D GMP GLP COA UV FTIR TOC IC UMCS DOP KF .

Quality Control Procedure General Analytical Method Microbiological Method Analytical Reference Number High Performance Liquid Chromatograph Active Pharmaceutical Ingredients Standard Operating Procedure Out Of Specification Instrument Operating. Procedure Equipment Operating Procedure Air Handling Unit Gas Chromatography Corporate Quality Assurance Disintegration test Compact Disc Research and Development Good Manufacturing Practices Good Laboratory Practices Certificate of Analysis Ultra Violet Fourier Transform Infra Red Total Organic Carbon Ion Chromatography : User Management policy and Control : Data Organization Procedure : Karl Fischer UPLC : Ultra Performance Liquid Chromatography

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ABBREVIATIONS: (Contd....) OOT OOAC

: Out-Of Trend Out Of Action limit

GOAL

Out Of Alert limit

REFERENCES: ICH Q7A.

QCP 23

Good Manufacturing Practice for active pharmaceutical ingredients. A WHO guide to good manufacturing practice (GMP) requirements. National Blood Service - Good Manufacturing Practice or GMP A Brief Guide. EU Guidelines . to Good Manufacturing Practice Medicinal Products for Human and Veterinary use. Schedule M and L. (Drugs and cosmetics act, 1940 and rules, 1945). . Laboratory Safety . . Laboratory Chemicals : . Sampling : . Receipt, Registration and Testing of samples : . Reserve Samples . Handling and Disposal of quality control samples . . Laboratory Reference Standards . Stability Studies : . Validation and Verification of Analytical Methods. : . Preparation of Certificate of Analysis Documents / Status Label Generation Through Controlled Software . Calibration and Maintenance of Analytical Instruments / Equipments

QCP 28 QCP 30 QCP 32

: . Forced Degradation Study : . Laboratory Sampling Accessories . Transfer of Analytical Methods

WHO NBS EudraLex Volume 4 Indian FDA QCP 02 QCP 03 QCP 06 QCP 07 QCP 08 QCP 09 QCP 14 QCP 15 QCP 16 QCP 18 QCP 21

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PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 46

REFERENCES: (Contd....)

QCP 34 QCP 38 QCP 47 QCP 50 QCP 52 QCP 54 QCP 62 QCP 63 QCP 64 QCP 68 QCP 72 QCP 73 QCP 74 QCP 76 QCP 77 CQA-31 CQA-37 CQA-39 CQA-51 CQA-54 CQA-191 CQA-193 CQA-311 CQA-3,14 CQA-324 MM 02 MM 03 MM 05 MM 31

: : :

Quality Control Documentation Analytical Incidences Investigation and Resolution Procedures Out-Of-Specification and Out-Of-Trend Investigation Procedure : Usage and Qualification of workstation : Laboratory Glassware : Out Of Specification Investigation and Resolution Procedure of Packaging Materials : Generation of Trend limit and monitoring trend of Quality Attributes : Temperature & Humidity Distribution Study in Quality Control : Good Chromatographic Practices : Review and Validation. of Security Functions of Software / Workstation : Walk-in chambers / incubators in the laboratory : Qualification of Analytical Instruments and software : Sampling of Water and Steam" Condensate : Analysis at Contract laboratory : Photostability Study : Training : Handling of Product Complaints : Audit of Contract Laboratory • : Deviation Handling : Self Inspection : Cleaning and sanitation of washing area and drainage points : Preparation, usage, storage and destruction of disinfectant, cleaning and deactivating solution. : Investigation of Abberations in Microbiological Test Results. : Organisation Chart and Job Responsibilities : Investigation of Sterility Test Positives : Cleaning and disinfection of Microbiology Laboratory : Monitoring of Microbiology Laboratory : Preparation and disposal of Microbial culture media : Validation/ verification of Bio assay methods

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Section: Quality Control Page. NO. 47

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PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 48

ANNEXURES: QCP01/A1 Laboratory cleaning procedure / checklist (QCP01/CL1/2) QCP01/A2 Record of Cleaning in Laboratory (QCP01/F23/1) QCP01/A3 Cleaning Record Of Water Bath For Dissolution Test Apparatus (QCP01/F27) QCP01/A4 Temperature record of dissolution vessel (QCP01/F24/1) QCP01/A5 Dissolution testing Observations sheet (QCP01/F25/1) QCP01/A6 Non Routine Validation Schedule (QCP01/F28) QCP01/A7 Label for Purified Water (QCP01/I.A3/1) QCP01/A8 Temperature and Humidity Record (QCP01/F7) QCP01/A9 Temperature and Humidity Record (ForDigitalDisplayThermohygrometer) (QCP01/F9/1) QCP01/A10 Temperature Record (QCP01/F812) QCP01/A11 Status label for HPLC / IC Analysis (QCP01/LA1/1) QCP01/Al2 Status label for GC Analysis (QCP01/LA7) QCP01/A13 Status label for Dissolution Test QCP01/A14 (QCP01/LA8/1) Status label for Analysis(for other major instruments /equipments) (QCP01/LA2/2) QCP01/A15 List of Authorised Users (QCP01/L1) QCP01/A16 Instrument Usage Log (For HPLC / IC/ GC) QCP01/A17 Instrument Usage Log (For instruments coulometer, KF, pH meter, Conductivity meter and Autotitrator) (QCP01/F26) QCP01/A18 Instrument / Equipment Usage Log (For instruments / equipments other than HPLC / IC, GC, KF, Coulometer, Conductivity meter, Autotitrator and pH meter) (QCP01/F5/2) QCP01/A19 HPLC / IC Column Usage And System Suitability Parameters Entry Log (QCP01/F1/4) QCP01/A20 GC Column Usage log (QCP01/F20) QCP01/A21 Electrode Usage Log (QCP01/F3/1) QCP01/A22 Label for Desiccant Replacement (QCP01/LA11)

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Section: Quality Control Page. NO. 49

ANNEXURES: (Contd....) QCP01/A23

: Desiccant Replacement Record (QCP01/F21/1)

QCP01/A24

: Label for Replacement of Water from Water batch (For Dissolution Tester, Disintegration Tester, Sonicators etc.) (QCP01/LA12)

QCP01/A25

: Label for Mobile Phase (QCP01/LA5/2)

QCP01/A26

: Label for Column / Syringe / Plunger Flushing (QCP01/LA6/2)

QCP01/A27

: Label for 'Diluent / Buffer / Dissolution Medium' (QCP01/LA13)

QCP01/A28

: Label for Karl Fischer Reagent (QCP01/LA9)

QCP01/A29 QCP01/A30

: Label for Methanol for Karl Fischer (QCP01/LA10) : Record of pH and Conductivity for purified water (QCP01/F11/2)

QCP01/A31

: Cleaning Agent / Disinfectant Solution Preparation Record (QCP01/F22/1) (Guideline Copy I and II) : Schematic display for Non-Conformances in the laboratory

QCP01/A32

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PRACTICAL GOOD LABORATORY PRACTICES

Title

Page. NO. 50

ANNEXURE QCP 01/A1 (specimen copy)

LABORATORY CLEANING PROCEDURE / CHECKLIST Month : Date Area Dust Bins

Remove the contents with the polythene bags and transfer to the house-keeping bin.

Work benches

Clean with dusters.

Wash tubs

Clean with soap solution and water.

Floor

Clean the floor with a vacuum cleaner or dry mopper with a disinfectant solution. Spray with soap solution and wipe with dry cloth.

W ind ow fram e s a nd g las s s hie ld s

Frequency

Procedure

1

2

3

4

5

6

7

…

25

26

27

28

29

30

31

Daily

Daily Daily Daily

Weekly

Aluminium frames / doors Grills of AHUs

Spray with soap solution and wipe with dry cloth.

Weekly

Spray with soap solution and wipe with dry cloth.

Fortnightly

Tube light frames / shields Instrument top

Remove the shields and clean them with a dry cloth. Clean with duster

Monthly Daily

Checked By

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Section: Quality Control Page. NO. 51

Disinfectant Solution A : Preparation of _____% of ____________ disinfectant solution : Add ________ ml of ______________________________________ disinfectant solution to a bucket containing _______ litres of water. To be used from period __________ to ___________ Disinfectant Solution B : Preparation of _____% of ____________ disinfectant solution : Add ________ ml of ______________________________________ disinfectant solution to a bucket containing _______ litres of water. To be used from period __________ to ____________ Note : Disinfectant solution should be rotated fortnightly.

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Good Documentation Practices Section: Quality Control

PRACTICAL GOOD LABORATORY PRACTICES

Title

Page. NO. 52

ANNEXURE QCP 01/A2 (Guideline Copy) RECORD OF CLEANING IN LABORATORY Month and Year : March 2021 Date

31

30

29

28

27

26

25

24

23

22

√ √

21

√ √ √

20

N

19

Dai ly

√ √

18

Glass ware drying oven(

√ √ √

17

N

16

Dai ly

√ √

15

Sonic ator (EBO8)

√ √ √

14

N

13

Dai ly

√ √

12

Water bath (EB285)

√ √ √

11

N

10

Dai ly

9

Dryin g oven (EB268)

8

(Name/Nu mber) Frequency

7

6

5

4

3

2

1

Area / Eqpt.

A

A

A

A

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Good Documentation Practices PRACTICAL GOOD LABORATORY PRACTICES

Title

Section: Quality Control Page. NO. 53

EB25) Refrig erator (EB389)

We ekl y

N A

√

Dry Box (EB14)

We ekl y

N A

√

Sampl e storag e comp artme nt (RM)

Fort

Sampl e storag e comp artme nt (FP)

Fort

Hydro

Fort

night

N A

√

ly

night

N A

√

ly

N

√

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Title

gen gener ator (EB353)

night

Weight

Mont

Box

hly

Weight

Mont

Box

hly

Section: Quality Control Page. NO. 54

A

ly

N A

√

N A

√

Checked by Remark: ___________________________________________________________________ Note: √Activity is completed NA — Not Applicable

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Section: Quality Control Page. NO. 55

ANNEXURE QCP 01/A3 (SPECImEN COPY)

CLEANING RECORD OF WATER BATH FOR DISSOLUTION TEST APPARATUS Equipment No.: Water Bath Cleaned on (Date)

Details of replacement of 0.01 % Cetylpyridinium chloride solution in purified water

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

------g in

------litre

CetylpyridiniumDone By chloride Batch No. / Mfg. Name

Checked By

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PRACTICAL GOOD LABORATORY PRACTICES

Title

Page. NO. 56

ANNEXURE QCP 01/A4 (SPECIMENT COPY) Authorized by : Head Quality Control: Date :

Issued by : Section Head : Date :

TEMPERATURE RECORD OF DISSOLUTION VESSEL Product : B.No. : A.R.No. :

Sr. No.

Date : Sign : Equipment No. :

Time Intervals 1

Dissolution Vessels

2

3

4

5

6

7

8

9

10

11

12

13

14

Checked by : Date :

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Section: Quality Control Page. NO. 57

ANNEXURE QCP 01/A5

(SPECIMENT COPY) Authorised by : Head Quality Control Date :

Issued by : Section Head Date : DISSOLUTION TESTING OBSERVATIONS SHEET

Product : A.R. No.: Weight of Tablet / Bowl Capsule / Unit Dose (g) No.

Batch No.: Equipment No.: Observations -----Minutes

-----Minutes

-----Minutes

1 2 3 4 5 6 7 8 9 10 11 12 13 14 Note : If observation is normal, record as OK. If it differs than the required, record the details of the same.

Remark :

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Done by : Date :

PRACTICAL GOOD LABORATORY PRACTICES

Section: Quality Control Page. NO. 58 Checked by : Date :

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PRACTICAL GOOD LABORATORY PRACTICES

Title

Page. NO. 59

ANNEXURE QCP 01/A6 (SPECIMENT COPY) NON ROUTINE VALIDATION SCHEDULE Unit :

Year :

Sr. No.:

Topic

Due on

Performed by (Sign / Date)

Reviewed by (Sign / Date)

1

Glassware cleaning validation

JAN - 2021

XYZ i 02.01.2021

A/3C / 05.01.2021

FEB - 2021

XYZ / 06.02.2021 A B C /

08.02.2021

sampling 2

accessories cleaning validation

3

temperature distribution study for ovens

March - 2021

XYZ / 08.03.2021

ABC / 10.03.2021

4

Sampling kit cleaning validation

APRIL -2021

XYZ / 06.04.2021

A'BC 2021 08 .04. /

5

Sampling room cleaning v a l i d a t i o n

MAY - 2021

05 .X0Y5Z2 /012

A013C / 5 08 ..2021

MAY - 2021

XYZ / 12.05.2021 741:3C /

15.05.2021

6

Dissolution

accessories cleaning validation (Bowl, paddle, canullas)

Remark

PREPARED BY

CHECKED BY

APPROVED BY

Section Head Date :

Head Quality Control Date :

Lab QA Head Date :

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Section: Quality Control Page. NO. 60

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Section: Quality Control Page. NO. 61

ANNEXURE QCP 01/A7 (SPECIMENT COPY)

Label for Purified water

Item : PURIFIED WATER Sign :

Date :

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Page. NO. 62

ANNEXURE QCP 01/A8 (SPECIMENT COPY)

TEMPERATURE AND HUMIDITY RECORD Area : Hygrometer Code No. :

Date

Time

Month and Year : Calibration Valid upto :

Reading on Hygrometer Limit : °C Limit : % RH Dry bulb Wet bulb Difference (°C) (°C) (°C)

Daily maintenance Humidity (% RH)

Wick

Water level

Cleaned / Changed

OK / Adjusted

Checked By

OK / Adjusted Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Cleaned / Changed

OK / Adjusted OK / Adjusted

Note : If the temperature / humidity is not within the limit immediately inform the Engineering

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Page. NO. 63

department nit Quality Assurance for corrective action. ANNEXURE QCP 01/A9 (SPECIMENT COPY) (For Digital Display Thermohygrometer)

TEMPERATURE AND HUMIDITY RECORD Area : Thermo hygrometer Code No. :

Month and Year : Calibration Valid upto :

Temperature °C Limit: Date

Time

Actual Temp.°C

Minimum Temp.°C

Humidity Limit: %RH Maximum Temp.°C

Actual Humidity % RH

Minimum Humidity % RH

Daily maintenance Maximum Humidity % RH

Resetting

Remark

Done! Not Done Done / Not Done Done / Not Done Done / Not Done Done! Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done Done / Not Done

OK/ Not OK OK! Not OK OK/ Not OK OK! Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK! Not OK OK/ Not OK OK! Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK/ Not OK OK! Not OK

Checked By (Sign/ Date)

Reviewed by (Sign/ Date)

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Note : If the temperature / humidity is not within the limit immediately inform the Engineering department and Unit Quality Assurance for corrective action.

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Page. NO. 65

ANNEXURE QCP 01/A10

(SPECIMENT COPY)

TEMPERATURE RECORD Instrument / Equipment Name : Instrument / Equipment No. Display unit / Thermometer Code No. : Observed Temperature Date Time °C Limit: C

Month and Year :

Remark

Calibration Valid upto : Checked by Reviewed by (Sign/Date) (Sign/Date)

OK / Not OK OK / Not OK OK/Not OK OK/Not OK OK/Not OK OK / Not OK OK / Not OK OK/Not OK OK/Not OK OK / Not OK OK/ Not OK OK/Not OK OK/Not OK OK/Not OK OK/Not OK OK/Not OK OK / Not OK OK / Not OK OK / Not OK OK / Not OK OK/Not OK OK/Not OK OK/Not OK OK / Not OK

Note : If the temperature is not within the limit immediately inform the Engineering department and Unit Quality Assurance for corrective action.

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Section: Quality Control Page. NO. 66

ANNEXURE QCP 01/All

(SPECIMENT COPY) Status label for HPLC / IC Analysis

ANALYSIS STATUS Inst. No. : Product Name : B. No./A. R. No. : Mobile Phase : Column No. : Test : Sign :

Date

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Page. NO. 67

ANNEXURE QCP01/A13

(SPECIMENT COPY) Status label for Dissolution Test

ANALYSIS STATUS Eqpt. No. : Product Name : B. No./A. R. No. : Medium : RPM. : Test : Sign :

Date :

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Annexure QCP01/A14 (SPECIMENT COPY) Status label for Analysis (For other major instruments / equipments)

ANALYSIS STATUS Inst. / Eqpt. No.: Product Name : B. No. / A. R. No. : Test : Sign :

Date :

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Section: Quality Control Page. NO. 69

ANNEXURE QCP01/A15 (SPECIMENT COPY) List of Authorised Users

AUTHORISED USERS Instrument No. : Instrument :

1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12) 13) Head Q.0 Sign :

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Date : QCP01/L1

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Section: Quality Control Page. NO. 70

ANNEXURE QCP 01/A16

(SPECIMENT COPY) (For HPLC / IC / GC)

INSTRUMENT USAGE LOG Instrument Name : Make : Model : Sr.No. Item

A.R. No.

Instrument Number : Month and Year : Start Date

Time Time

Started by

End Date

Time

Completed by

Remark

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Section: Quality Control Page. NO. 71

ANNEXURE QCP01/A18 (SPECIMENT COPY) (For instruments/equipments other than HPLC / IC, GC, KF, Coulometer, Conductivity meter, Autotitrator and pH meter)

Instrument Name : Make : Model : ` No.

Date

INSTRUMENT / EQUIPMENT USAGE LOG Instrument Number : Month and year :

Item/Product

A.R. No.

User

Remark

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Page. NO. 72

ANNEXURE QCP 01/A19

(SPECIMENT COPY)

HPLC / IC COLUMN USAGE AND SYSTEM SUITABILITY PARAMETERS ENTRY LOG Column No.

Sr. No.

Date/ A.R. No.

Make

No. of Item / Injections Product

Serial No.

Test

Peak Name

Type

Resolution Limit

Result

ID (mm)

Theoretical Plates Limit

Result

Length (mm)

Tailing Factor Limit

Result

Particle Size (p)

Capacity Factor Limit

Remark

User

Result

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Page. NO. 73

ANNEXURE QCP 01/A20

(SPECIMENT COPY) GC COLUMN USAGE LOG Column No.

Make

A.R. No. Product name

Serial No.

Start —

Date

Time

Type

Started by

ID (mm)

No. of injections

Length (M)

End Date

Time

Particle size (Micron)

Completed Remark by

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Section: Quality Control Page. NO. 74

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Section: Quality Control Page. NO. 75

ANNEXURE QCP 01/A21 (SPECIMENT COPY)

ELECTRODE USAGE LOG Electrode Details : Electrode No. : Date Product

A.R. No.

Sign

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Section: Quality Control Page. NO. 76

ANNEXURE QCP01/A22 (SPECIMENT COPY) Label for Desiccant Replacement

Code No. : Desiccant Replaced on : Replacement Due Date : Sign :

Date :

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Page. NO. 77

ANNEXURE QCP 01/A23 (SPECIMENT COPY)

DESICCANT REPLACEMENT RECORD __ Name

_

Num ber

Freque ncy

`Date 1

2

3

4

5 6

Daily

N A

√ √ √ √

√

7 8 9 1 0

1 1

12

UV spectrophot ometer

IB-85

UV

IB-86

Daily

N A

√ √ √

√

IB153

Daily

N A

√ √ √

√

Density meter

IB-07

Weekly

N A

√

Coulometer

IB140

Weekly

N A

√

Autotitrator

IB146

Weekly

N A

√

Karl Fischer

IB-10

Weekly

N A

√

Desiccator

GIDO1

fortnight ly

N A

Desiccator

GIDO 8

fortnight ly

N A

Desiccator

GID1 0

fortnight ly

N A

-

Desiccator

GIDO 5

fortnight ly

N A

√

spectrophot ometer

IR Spectrophot ometer

1 3

1 4

1 5

1 6

1 7

1 8

1 9

2 0

2 1

2 2

2 3

2 4

2 5

2 6

2 7

2 8

2 9

3 0

3 1

√ √ √

Checked by

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Section: Quality Control Page. NO. 78

Remark : Note :

√- Activity is completed,

NA — Not Applicable

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Page. NO. 79

ANNEXURE QCP01/A24

(SPECIMENT COPY) Label for Replacement of Water from Water bath (For Dissolution Tester, Disintegration Tester, Sonicators etc.)

Water replacement from water bath Inst. / Eqpt. Name : Inst. / Eqpt. No. : Done On : Due On : Done by : Sign :

Date :

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Section: Quality Control Page. NO. 80

ANNEXURE QCP01/A25 (SPECIMENT COPY)

Label for Mobile Phase

Mobile Phase for : A.R. No.: Valid Up to : Time : Sign :

Date :

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Section: Quality Control Page. NO. 81

ANNEXURE QCP01/A26 (SPECIMENT COPY)

Label for Column / Syringe / Plunger Flushing

COLUMN/SYRINGE/PLUNGER FLUSHING Solvent : Date of Dispensing/preparation on: Valid Up to : Time : Sign : Date :

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Section: Quality Control Page. NO. 82

ANNEXURE QCP01/A27

(SPECIMENT COPY) Label for 'Diluent / Buffer / Dissolution Medium

Diluent / Buffer / Dissolution Medium for : A.R. No.: Test : Sign :

Date :

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Section: Quality Control Page. NO. 83

ANNEXURE QCP01/A28

(SPECIMENT COPY) Label for Karl fischer Reagent

KARL FISCHER REAGENT Batch No. : Valid upto : Sign : Date :

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ANNEXURE QCP01/A29 (SPECIMENT COPY) Label for Methanol for Karl Fischer

METHANOL FOR KARL FISCHER Batch No. : Manufacturer : Valid upto : Sign : Date :

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Section: Quality Control Page. NO. 85

ANNEXURE QCP01/A30 (SPECIMENT COPY) RECORD OF pH AND CONDUCTIVITY FOR PURIFIED WATER Month and Year : Limits for pH and Conductivity referred from Specification No. : Date

pH

Conductivity

Remark

Done by

Checked by

Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply Complies / Does not comply

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Page. NO. 86

ANNEXURE QCP 01/A31 (SPECIMENT COPY)

CLEANING AGENT / DISINFECTANT SOLUTION PREPARATION RECORD Item : Ortho-Phosphoric Acid solution. Concentration: 1% v/v Date Volume of

(Ortho-Phosphoric Acid)

9.02.2021 10 ml

Volume of Diluent

(water )

990 ml

Page of. Prepared By

Jack

Checked By

Molani .eer

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Page. NO. 87

ANNEXURE QCP 01/A31 (SPECIMENT COPY)

CLEANING AGENT/DISINFECTANT SOLUTION PREPARATION RECORD

Item: teepoL

solution Concentration: 2 % V/V Date

Volume of ( teepok__)

Volume of Diluent ( Water)

9.02.2021

10 ml

990 ml

Page of . Prepared By

Jack

Checked By

Molani .eer

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Section: Quality Control Page. NO. 88

ANNEXURE QCP 01/A32

OOS and OOT for chemical : (QCP 47) OOS for Packaging Material : (QCP 54) OOS / OOAC / OOAL / OOT for Microbiological and Sterility tests : (CQA-311 and CQA-324) Test results do not meet established specification and trend limit.

Analytical Incidences : (QCP 38) All errors other than OOS / OOT.

NON CONFORMANCE IN LABORATORY

Excursion in temperature and humidity : (QCP 72) The non-conformances like excursion of Temperature / Humidity of the walk-in chambers / incubators.

Deviation : (CQA-51) The departure from an approved written instructions or established standards.

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Section: Quality Control Page. NO. 89

TABLE OF REVIEWS ITEM : GOOD LABORATORY PRACTICES DOCUMENT : QCP 01 Changes Version Date of No. Review

07

9.02.2021

Page 1 of 1

Refer Attached annexure of change control No. LD/CPC/21/02/035.

Name of Reviewer

Jack Molani

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