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Good Laboratory Practices for
Pharmaceuticals and Biopharmaceuticals
By
Dr. Basavaraj Nanjwade M. Pharm., PhD.
Assistant Vice President and Plant Head
KJD Pharmaceuticals Pvt Ltd., Bidar.
By
Dr. Basavaraj Nanjwade M. Pharm., PhD
Assist. Vice President and Plant Head
KJD Pharmaceuticals Pvt Ltd
BIDAR-585402, Karnataka, India.
31/05/2021 1
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
CONTENTS
• Objective
• Definition
• General
• Premises and Utilities
• Personnel
• Training
• Instruments / Equipments / Accessories
• Validation / Verification of Analytical Methods
• Sampling
• Testing and Reporting
• Stability Studies
• Chemicals , Reagents, Glassware and Analytical Standards
• Documentation
• Results of Not Following GLP in Laboratory
• Conclusion
31/05/2021 2
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Objective
To lay down the procedure for Good Laboratory Practices to
be followed to obtain reliable and reproducible results,
meeting regulatory standards with effective usage of time,
manpower and resources.
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 3
Definition
Good Laboratory Practice embodies a set of principles that
provides a framework within which laboratory studies
(Activities) are planned, performed, monitored, recorded,
reported and archived.
GLP help 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 marking
risk/safety assessment.
31/05/2021 4
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
General
GLP/GMP concern all people who work in areas where it
applies, whether they are managers, supervisors or staff, it
also effects those “Indirectly” involved, in activities such as
maintenance, cleaning, record keeping and in ‘Support’
areas such as the personnel department etc.
31/05/2021 5
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
• Make sure to have the correct written instructions before
starting a task.
• Do not carry out task for which you have not been trained.
• Always follow instructions precisely,
• Keep records of information, results and actions taken.
• Check that the instrument / equipment / material used are
clean,
• Labels should always be held securely and not left lying
around.
General
31/05/2021 6
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
General
• Clean the glassware drying oven, refrigerator, walk in
chamber incubators, water bath of the instruments like
dissolution tester, disintegration testers etc, used in the
quality control laboratory as per the procedure.
• While closing the Quality Control Laboratory, ensure that all
water taps, instruments (which are not running),
equipments, computers are put ‘OFF’.
• Put off the lights, AC’s and closes the department.
• The laboratory main door keys should be submitted to
security department.
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 7
Premises and Utilities
• Maintain the laboratory and its premises clean
• Clean and disinfect the sterile and microbiological testing
areas
• Quality Control personals should avoid mix-ups and cross
contamination during analysis.
• Keep work benches of laboratories clean and tidy all the
time.
• Keep the samples, standards, laboratory reagent,
apparatus, accessories and records at adequate and
suitable storage space.
31/05/2021 8
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Premises and Utilities
• For analytical preparation wherever water is to be used, use
‘purified water’ for chromatographic analysis like HPLC, GC,
etc.
• Use HPLC grade water or water generated by Milli-Q system.
• The utilities like compressed air, vacuum required for the
functioning of laboratory should have identification mark.
• Maintain temperature and humidity record as per respective
procedure wherever applicable.
• Follow the procedure in case access control system is to be
followed where restricted entry is necessary.
31/05/2021 9
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Premises and Utilities
• In case of hazardous and poisonous materials, keep it
at adequate storage area/facility with lock and key to
avoid misuse.
• Also keep reserve sample, stability sample, laboratory
standards in lock and key.
• Use eye washer, water shower, first aid kit etc. in case
of emergency which may arise during operation.
• Always identify the location of emergency exit in the
laboratory for exit during emergency.
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 10
Personnel
• All personnel prior to employment should be periodically re-
examined for medical fitness.
• The Quality Control Manager should ensure that the
personnel are medically fit to carry out the job.
• Personnel suffering from an infectious disease
• All employees shall be instructed to report about their
illness or abnormal health condition to their immediate
supervisor so that appropriate action can be taken.
31/05/2021 11
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Personnel
• The job responsibility should be assigned according to
competency of the person.
• Personnel should practice good sanitization and health
habits.
• Smoking, eating, drinking, chilling, food, drinks and
personnel medicine should not be permitted in laboratories
area,
31/05/2021 12
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Personnel
• Personnel should strictly follow entry/exit and gowning
procedure.
• While handling hazardous chemicals and while performing
sterility, microbiological analysis, procedure of change of
clothing and use of personnel protective equipments and
safety appliances should be strictly followed.
• Never handle any chemicals, raw materials intermediate or
finished, unpacked product with bare hands.
• Always use the appropriate hand gloves while handling the
same.
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 13
Training
• Training should be regularly conducted by qualified
individuals and should cover,
• 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.
• Records of training must be maintained.
• Training should be periodically accessed.
• All staff, including new staff and existing staff should be
given basic training on Good Laboratory Practices during
induction and at regular intervals subsequently.
31/05/2021 14
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Instruments / Equipments / Accessories
• The analytical instrument shall be house in dust free
environment and whenever required, conditions of
temperature and humidity shall be maintained at periodic
checks of temperature and humidity be made and
recorded.
• All instruments / Equipments shall be qualified properly
through IQ, OQ and PQ activities after receive in the
laboratory.
• Instruments requiring calibration shall be calibrated at
regular intervals.
31/05/2021 15
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Instruments / Equipments / Accessories
• Other equipment/accessory such as burette, pipette, volumetric
flask, weight boxes, thermometers, etc, shall be thoroughly
checked for accuracy of calibration before acceptance for use.
• Computerized systems should have sufficient controls to
prevent unauthorized access or changes to data.
• Software should not be left opened and unattended to avoid
misuse.
• After use, save the data and close all operating system properly
and then switch off the computer system.
• Water from instrument / equipment (e.g. Dissolution, DT,
Sonicators, etc.) should be changed regularly.
31/05/2021 16
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Validation / Verification of Analytical
Methods
• All the analytical procedures shall be validated and
documentation of each validation phase should be
documented.
• A written protocol should be established that specifies how
Validation/Verification will be conducted.
• The protocol should be reviewed, approved and authorized
by the designated authorities.
• A Validation/Verification report should be prepared,
summarizing the results obtained.
31/05/2021 17
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Sampling
• Sampling should be done in accordance with approved
written procedure.
• The procedure should describe.
• Equipment 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.
• Any special precaution to be taken.
31/05/2021 18
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Sampling
• Storage condition.
• Instruction for cleaning and storage of sampling
equipments.
• Sampling staff should trained for sampling activity and
should have the knowledge of the nature of the samples to
be handled and should refer respective specifications for
the same.
• Sampled containers should be adequately labelled and
should have information for traceability.
31/05/2021 19
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Testing and Reporting
• There should be written procedure for testing materials and
products at different stage of manufacture, describing the
methods and instruments / equipments to be used.
• 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.
31/05/2021 20
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Testing and Reporting
• Use clean spatulas or butter papers for transferring and weighing
samples .
• Attach all relevant analytical raw data obtained from instruments
such as Analytical Balances, High Performance Liquid
Chromatograph, Gas Chromatograph, UV-Spectrophotometer, IR-
Spectrophotometer, Polarimeter, Refractometer, Potentiometer, Bulk
Density Apparatus, to the record of analysis / calculation sheet.
• In case of analysis of temperature sensitive material stored at 2-8°C
or in freezer (between -25°C to -10°C).
• During analysis, if any abnormal or unexpected event or out of
specification results occurs, address the same using a Incident
Report or out of specification report & analysts shall report all
Incidents and OOS to the Supervisor or Quality Control Manager as
soon as possible.
31/05/2021 21
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Stability Studies
• 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.
• A schedule should be designed to monitor the stability of
each product.
31/05/2021 22
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Stability Studies
• Product failures should be promptly reported to technical head,
regulatory affairs, R and D, quality assurance and customer, (if
applicable), for necessary action.
• The possible impact on the batches distributed in the market
should be considered.
• A summary of data generated should be written and maintained.
• This summary should be subjected to periodic review.
31/05/2021 23
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Chemicals , Reagents, Glassware
and Analytical Standards
• Special attention should be given to the quality of
laboratory reagents, volumetric glassware and solutions,
standards, and culture media.
• All reagents and solutions in the laboratory shall 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.
• Check the validity period of chemicals before use.
• Discard all expired chemicals and reagents.
31/05/2021 24
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Chemicals, Reagents, Glassware
and Analytical Standards
• Adequate space with proper storage condition in the
laboratory shall be provided for keeping reference and
working standards and be maintained by the quality control
department.
• The standards and solutions should be labelled.
• All the solutions, solvents dispensed and solvent waste
collected in vessel / beaker should be covered entirely with
appropriate cover e.g. using aluminium foil / glass lead etc.
to avoid the probable contamination as well as exposure of
the solvent vapours in the laboratory.
31/05/2021 25
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Chemicals, Reagents, Glassware
and Analytical Standards
• 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.
• Glassware can be labelled with glass marker pen or proper
sticker label.
• The glassware should be examined before use for
cleanliness and damage; do not use cracked, chipped or
any other defective glassware.
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 26
Documentation
• Specifications, instructions, procedures and records must
be free from errors and available in writing.
• Documents should be approved, sign and dated by
appropriate and authorized persons.
• Strict adherence to documented procedures and
specifications should be ensured.
• Documents should be regularly reviewed and kept up-to-
date.
31/05/2021 27
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Documentation
• There should be no over writing and correction fluid/ eraser
should not be used.
• Records should be made or completed at the time each
action is taken and in such a way that all significant
activities are traceable.
• Document should be preserved appropriately (Product /
Material wise or AR NO. wise) for easy retrieval and for
appropriate time.
31/05/2021 28
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
Results of Not following GLP in
Laboratory
• Accident/Incident & Health Hazards
• Wrong/error in volume or weight measurement which may
leads to wrong results.
• May leads to Instrument errors/Malfunctions
• Contamination of sample, reagent & solvent which may
affect the product quality to be tested.
• Due to wrong result it may affect patient safety.
• Regulatory agency may take action results in warning letter,
import alert etc.
• No evidence or documented proof of data generated
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 29
GOOD LABORATORY PRACTICE
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 30
Conclusion
• Everyone makes mistakes that’s why GLP is needed.
• Say What You Do (with written standard operating
procedures), do what you say (follow the procedures), be
able to prove it (with good record keeping).
• The principles of good laboratory practice (GLP) is to
support the development of quality.
• Hence GLP aims to decrease the occurrence of mistakes
or mix-ups through large and specific labelling
requirements.
• So every analyst those who are working in Quality control
or in other testing laboratory should follow GLP.
31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 31
THANK YOU
E-mail: nanjwadebk@gmail.com
Mob#: 0091 9742999277
31/05/2021 32
The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India

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Good laboratory practices for pharmaceuticals and biopharmaceuticals

  • 1. Good Laboratory Practices for Pharmaceuticals and Biopharmaceuticals By Dr. Basavaraj Nanjwade M. Pharm., PhD. Assistant Vice President and Plant Head KJD Pharmaceuticals Pvt Ltd., Bidar. By Dr. Basavaraj Nanjwade M. Pharm., PhD Assist. Vice President and Plant Head KJD Pharmaceuticals Pvt Ltd BIDAR-585402, Karnataka, India. 31/05/2021 1 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 2. CONTENTS • Objective • Definition • General • Premises and Utilities • Personnel • Training • Instruments / Equipments / Accessories • Validation / Verification of Analytical Methods • Sampling • Testing and Reporting • Stability Studies • Chemicals , Reagents, Glassware and Analytical Standards • Documentation • Results of Not Following GLP in Laboratory • Conclusion 31/05/2021 2 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 3. Objective To lay down the procedure for Good Laboratory Practices to be followed to obtain reliable and reproducible results, meeting regulatory standards with effective usage of time, manpower and resources. 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 3
  • 4. Definition Good Laboratory Practice embodies a set of principles that provides a framework within which laboratory studies (Activities) are planned, performed, monitored, recorded, reported and archived. GLP help 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 marking risk/safety assessment. 31/05/2021 4 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 5. General GLP/GMP concern all people who work in areas where it applies, whether they are managers, supervisors or staff, it also effects those “Indirectly” involved, in activities such as maintenance, cleaning, record keeping and in ‘Support’ areas such as the personnel department etc. 31/05/2021 5 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 6. • Make sure to have the correct written instructions before starting a task. • Do not carry out task for which you have not been trained. • Always follow instructions precisely, • Keep records of information, results and actions taken. • Check that the instrument / equipment / material used are clean, • Labels should always be held securely and not left lying around. General 31/05/2021 6 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 7. General • Clean the glassware drying oven, refrigerator, walk in chamber incubators, water bath of the instruments like dissolution tester, disintegration testers etc, used in the quality control laboratory as per the procedure. • While closing the Quality Control Laboratory, ensure that all water taps, instruments (which are not running), equipments, computers are put ‘OFF’. • Put off the lights, AC’s and closes the department. • The laboratory main door keys should be submitted to security department. 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 7
  • 8. Premises and Utilities • Maintain the laboratory and its premises clean • Clean and disinfect the sterile and microbiological testing areas • Quality Control personals should avoid mix-ups and cross contamination during analysis. • Keep work benches of laboratories clean and tidy all the time. • Keep the samples, standards, laboratory reagent, apparatus, accessories and records at adequate and suitable storage space. 31/05/2021 8 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 9. Premises and Utilities • For analytical preparation wherever water is to be used, use ‘purified water’ for chromatographic analysis like HPLC, GC, etc. • Use HPLC grade water or water generated by Milli-Q system. • The utilities like compressed air, vacuum required for the functioning of laboratory should have identification mark. • Maintain temperature and humidity record as per respective procedure wherever applicable. • Follow the procedure in case access control system is to be followed where restricted entry is necessary. 31/05/2021 9 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 10. Premises and Utilities • In case of hazardous and poisonous materials, keep it at adequate storage area/facility with lock and key to avoid misuse. • Also keep reserve sample, stability sample, laboratory standards in lock and key. • Use eye washer, water shower, first aid kit etc. in case of emergency which may arise during operation. • Always identify the location of emergency exit in the laboratory for exit during emergency. 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 10
  • 11. Personnel • All personnel prior to employment should be periodically re- examined for medical fitness. • The Quality Control Manager should ensure that the personnel are medically fit to carry out the job. • Personnel suffering from an infectious disease • All employees shall be instructed to report about their illness or abnormal health condition to their immediate supervisor so that appropriate action can be taken. 31/05/2021 11 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 12. Personnel • The job responsibility should be assigned according to competency of the person. • Personnel should practice good sanitization and health habits. • Smoking, eating, drinking, chilling, food, drinks and personnel medicine should not be permitted in laboratories area, 31/05/2021 12 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 13. Personnel • Personnel should strictly follow entry/exit and gowning procedure. • While handling hazardous chemicals and while performing sterility, microbiological analysis, procedure of change of clothing and use of personnel protective equipments and safety appliances should be strictly followed. • Never handle any chemicals, raw materials intermediate or finished, unpacked product with bare hands. • Always use the appropriate hand gloves while handling the same. 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 13
  • 14. Training • Training should be regularly conducted by qualified individuals and should cover, • 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. • Records of training must be maintained. • Training should be periodically accessed. • All staff, including new staff and existing staff should be given basic training on Good Laboratory Practices during induction and at regular intervals subsequently. 31/05/2021 14 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 15. Instruments / Equipments / Accessories • The analytical instrument shall be house in dust free environment and whenever required, conditions of temperature and humidity shall be maintained at periodic checks of temperature and humidity be made and recorded. • All instruments / Equipments shall be qualified properly through IQ, OQ and PQ activities after receive in the laboratory. • Instruments requiring calibration shall be calibrated at regular intervals. 31/05/2021 15 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 16. Instruments / Equipments / Accessories • Other equipment/accessory such as burette, pipette, volumetric flask, weight boxes, thermometers, etc, shall be thoroughly checked for accuracy of calibration before acceptance for use. • Computerized systems should have sufficient controls to prevent unauthorized access or changes to data. • Software should not be left opened and unattended to avoid misuse. • After use, save the data and close all operating system properly and then switch off the computer system. • Water from instrument / equipment (e.g. Dissolution, DT, Sonicators, etc.) should be changed regularly. 31/05/2021 16 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 17. Validation / Verification of Analytical Methods • All the analytical procedures shall be validated and documentation of each validation phase should be documented. • A written protocol should be established that specifies how Validation/Verification will be conducted. • The protocol should be reviewed, approved and authorized by the designated authorities. • A Validation/Verification report should be prepared, summarizing the results obtained. 31/05/2021 17 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 18. Sampling • Sampling should be done in accordance with approved written procedure. • The procedure should describe. • Equipment 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. • Any special precaution to be taken. 31/05/2021 18 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 19. Sampling • Storage condition. • Instruction for cleaning and storage of sampling equipments. • Sampling staff should trained for sampling activity and should have the knowledge of the nature of the samples to be handled and should refer respective specifications for the same. • Sampled containers should be adequately labelled and should have information for traceability. 31/05/2021 19 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 20. Testing and Reporting • There should be written procedure for testing materials and products at different stage of manufacture, describing the methods and instruments / equipments to be used. • 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. 31/05/2021 20 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 21. Testing and Reporting • Use clean spatulas or butter papers for transferring and weighing samples . • Attach all relevant analytical raw data obtained from instruments such as Analytical Balances, High Performance Liquid Chromatograph, Gas Chromatograph, UV-Spectrophotometer, IR- Spectrophotometer, Polarimeter, Refractometer, Potentiometer, Bulk Density Apparatus, to the record of analysis / calculation sheet. • In case of analysis of temperature sensitive material stored at 2-8°C or in freezer (between -25°C to -10°C). • During analysis, if any abnormal or unexpected event or out of specification results occurs, address the same using a Incident Report or out of specification report & analysts shall report all Incidents and OOS to the Supervisor or Quality Control Manager as soon as possible. 31/05/2021 21 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 22. Stability Studies • 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. • A schedule should be designed to monitor the stability of each product. 31/05/2021 22 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 23. Stability Studies • Product failures should be promptly reported to technical head, regulatory affairs, R and D, quality assurance and customer, (if applicable), for necessary action. • The possible impact on the batches distributed in the market should be considered. • A summary of data generated should be written and maintained. • This summary should be subjected to periodic review. 31/05/2021 23 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 24. Chemicals , Reagents, Glassware and Analytical Standards • Special attention should be given to the quality of laboratory reagents, volumetric glassware and solutions, standards, and culture media. • All reagents and solutions in the laboratory shall 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. • Check the validity period of chemicals before use. • Discard all expired chemicals and reagents. 31/05/2021 24 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 25. Chemicals, Reagents, Glassware and Analytical Standards • Adequate space with proper storage condition in the laboratory shall be provided for keeping reference and working standards and be maintained by the quality control department. • The standards and solutions should be labelled. • All the solutions, solvents dispensed and solvent waste collected in vessel / beaker should be covered entirely with appropriate cover e.g. using aluminium foil / glass lead etc. to avoid the probable contamination as well as exposure of the solvent vapours in the laboratory. 31/05/2021 25 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 26. Chemicals, Reagents, Glassware and Analytical Standards • 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. • Glassware can be labelled with glass marker pen or proper sticker label. • The glassware should be examined before use for cleanliness and damage; do not use cracked, chipped or any other defective glassware. 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 26
  • 27. Documentation • Specifications, instructions, procedures and records must be free from errors and available in writing. • Documents should be approved, sign and dated by appropriate and authorized persons. • Strict adherence to documented procedures and specifications should be ensured. • Documents should be regularly reviewed and kept up-to- date. 31/05/2021 27 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 28. Documentation • There should be no over writing and correction fluid/ eraser should not be used. • Records should be made or completed at the time each action is taken and in such a way that all significant activities are traceable. • Document should be preserved appropriately (Product / Material wise or AR NO. wise) for easy retrieval and for appropriate time. 31/05/2021 28 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India
  • 29. Results of Not following GLP in Laboratory • Accident/Incident & Health Hazards • Wrong/error in volume or weight measurement which may leads to wrong results. • May leads to Instrument errors/Malfunctions • Contamination of sample, reagent & solvent which may affect the product quality to be tested. • Due to wrong result it may affect patient safety. • Regulatory agency may take action results in warning letter, import alert etc. • No evidence or documented proof of data generated 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 29
  • 30. GOOD LABORATORY PRACTICE 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 30
  • 31. Conclusion • Everyone makes mistakes that’s why GLP is needed. • Say What You Do (with written standard operating procedures), do what you say (follow the procedures), be able to prove it (with good record keeping). • The principles of good laboratory practice (GLP) is to support the development of quality. • Hence GLP aims to decrease the occurrence of mistakes or mix-ups through large and specific labelling requirements. • So every analyst those who are working in Quality control or in other testing laboratory should follow GLP. 31/05/2021 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India 31
  • 32. THANK YOU E-mail: nanjwadebk@gmail.com Mob#: 0091 9742999277 31/05/2021 32 The Oxford College of Pharmacy, Bengaluru-560068, Karnataka, India