This document provides an overview of Good Laboratory Practice (GLP) principles established by the Organization for Economic Co-operation and Development (OECD). GLP was created in response to cases of fraudulent laboratory practices and aims to ensure the quality and validity of non-clinical safety studies. The key principles include requirements for test facility organization, quality assurance programs, facilities, equipment, test systems, test items, standard operating procedures, study conduct, reporting, and record keeping. Following GLP aims to yield data that accurately reflect study results and ensure international acceptance of safety tests.

1. WELCOME
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2. CONCEPT OF GLP AND
OECD PRINCIPLES OF GLP
ANUPAMA RAMACHANDRAN
M PHARM , PHARMACOLOGY
SECOND SEMESTER
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3. CONTENTS
• INTRODUCTION
• OECD
• OBJECTIVES
• PRINCIPLES OF GLP
• BENEFITS
• GLP IN OUR COUNTRY
• CONCLUTION
• REFERENCE
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4. WHAT IS A GOOD
LABORATORY PRACTICE ?
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5. Good Laboratory Practice (GLP) is a quality system
concerned with the organizational process and the
conditions under which non-clinical health and
environmental safety studies are planned, performed,
monitored, recorded, archived and reported
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6. WHY WAS GLP CREATED?
• In the early 70’s FDA became aware of cases of
poor laboratory practice all over the United
States.
• They discovered a lot fraudulent activities and a
lot of poor lab practices.
1. Equipment not been calibrated to standard
form therefore giving wrong measurements.
2. Incorrect/inaccurate accounts of the actual lab
study.
3. Inadequate test systems. 6

7. • One investigation- made headline news
• Lab - IBT
• Mice that they had used to test developed cancer and died.
• IBT lab threw the dead mice and covered results deeming the
products good for human consumption.
• Those involved in production, distribution and sales for the lab
eventually served jail time
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8. GLP was instituted in US following cases of fraud generated by
toxicology labs in data submitted to the FDA by pharmaceutical
companies. As a result of these findings, FDA promulgated the
Good Laboratory Practice (GLP) Regulations, 21 CFR part 58,
on December 22, 1978 (43FR 59986). The regulations became
effective on June 1979.
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9. As an international standard:
In 1981 an organization named OECD produced GLP
principles that are international standards of the OECD
Council, data generated in the testing of chemicals in one
OECD Member Country, in accordance with OECD Test
Guidelines and the Principles of GLP are accepted in all
other OECD Member Countries
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10. OECD
• An intergovernmental organization.
• Representatives of 30 industrialized countries in North America,
Europe, Pacific and the European Commission.
• To co-ordinate and harmonize policies, discuss issues of mutual
concern, and work together to respond to international problems
• The Principles of GLP have been developed to promote the quality
and validity of test data used for determining the safety of chemicals
and chemical products
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11. OBJECTIVES OF GLP
• data submitted are a true reflection of the results that are
obtained during the study.
• not to indulge in any fraud activity by labs.
• international acceptance of tests
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12. GOOD LABORATORY
PRACTICE
PRINCIPLES
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13. GOOD LABORATORY PRACTICE -
PRINCIPLES
1.Test Facility Organization and Personnel
2. Quality Assurance Program
3. Facilities
4. Apparatus, Material, and Reagents
5. Test Systems
6. Test and Reference Items
7. SOPs
8. Performance of the Study
9. Reporting of Study Results
10. Storage and Retention of Records and Materials
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14. 1.Test Facility Organization and Personnel
A. Test Facility Management’s Responsibilities
B. Study Director’s Responsibilities
C. Principal Investigator’s Responsibilities
D. Study Personnel’s Responsibilities
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15. A)Test Facility Management’s Responsibilities.
• Sufficient no. of qualified personnel, appropriate facilities,
equipment, and materials are available for the timely and
proper conduct of the Study
• Maintenance of a record of the qualifications, training,
experience.
• Job description for each professional and technical individual.
• Documented approval of the study plan by the Study Director.
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16. B. Study Director’s Responsibilities.
• Approve the study plan.
• Any amendments to the study plan by dated Signature.
• Availability of SOPS to the personnel.
• Raw data generated are fully documented and recorded.
• Computerized systems used in the study have been validated.
• Sign and date the final report to indicate acceptance of responsibility for the
validity of the data.
• Ensure that after completion of the study, the study plan, the final report,
raw data and supporting material are archived.
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17. C. Principal Investigator’s Responsibilities
Ensure that the delegated phases of the study are conducted in
accordance with the applicable Principles of Good Laboratory Practice
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18. 2.Quality Assurance Program
1.Quality assurance personnel
2.Study plan contains the information-verification
3.conduct inspections
4.Records of such inspection should be retained
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19. 3. Facilities
• Isolation of test systems and the isolation of individual projects involving
substances or organisms known to be or suspected of being bio hazardous.
• Areas as needed for supplies and equipment.
• Areas should be available for the diagnosis, treatment and control of diseases, in
order to ensure that there is no unacceptable degree of deterioration of test systems
Test system facilities
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20. Archive Facilities
• Provided for the secure storage and retrieval of study plans,
raw data, final reports, samples of test items and specimens.
• Archive design and archive conditions should protect contents
from deterioration
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21. Waste disposal
Handling and disposal of wastes should be carried out in such a
way as not to jeopardise the integrity of studies. This includes
provision for appropriate collection, storage and disposal
facilities, and decontamination and transportation procedures
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22. 4. Apparatus, Material, and Reagents
• Apparatus, including validated computerized systems, used for the generation, storage
and retrieval of data, and for controlling environmental factors relevant to the study.
• Apparatus used in a study should be periodically inspected, cleaned, maintained, and
calibrated according to SOPs
• Apparatus and materials used in a study should not interfere adversely with the test
systems.
• Chemicals, reagents, and solutions should be labeled to indicate
identity, expiry date and specific storage instructions.
• Information concerning source, preparation date and stability should be available.
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23. 5) Test Systems
• Physical and chemical test systems.
• Biological test systems.
• Records of source, date of arrival, and arrival conditions of test systems.
• Proper identification of test systems in their container or when removed.
• Cleaning and sanitization of containers.
• Pest control agents to be documented
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24. 6. Test and Reference Items
• Receipt, handling, sampling and storage
• Characterization.
• Known stability of test and reference items.
• Stability of the test item in its vehicle (container).
• Experiments to determine stability in tank mixers used in the field studies.
• Samples for analytical purposes for each batch
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25. 7.Standard Operating
Procedures (SOP)
• Written procedures for a laboratories program.
• They define how to carry out protocol specified activities.
• Most often written in a chronological listing of action steps.
• They are written to explain how the procedures are suppose to
work
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26. • Routine inspection, cleaning, maintenance, testing and
calibration.
• Actions to be taken in response to equipment failure.
• Keeping records, reporting, storage, mixing, and retrieval of
data.
• Definition of raw data.
• Analytical methods
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27. 8).Performance of the Study
A. Study Plan
B. Content of the Study Plan
C. Dates
D. Test Methods
E. Issues (where applicable)
F. Records.
G. A list of records to be retained.
H. Conduct of the Study.
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28. STUDY PLAN
• Identification of the study, the test item and reference item.
• Information concerning the sponsor and the test facility.
• Dates
• Test Methods
• Records
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29. CONDUCT OF THE STUDY
• A unique identification should be given to each study, all items concerning this
study should carry this identification
• Specimens from the study should be identified to confirm their origin.
• Conducted in accordance with the study plan
• Data generated should be recorded directly, promptly, accurately and signed
and dated
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30. 9).Reporting of Study Results
• The final report should be signed and dated by the SD to indicate
acceptance of responsibility for the validity of the data.
• The extent of compliance with the principles of GLP should be indicated.
• Amendments should clearly specify the reason for the corrections or
additions and should be signed and dated by the SD
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31. 10) Storage and Retention of Records
and Materials
• The study plan, raw data, samples.
• Inspection data and master schedules.
• SOPs.
• Maintenance and calibration data.
• If any study material is disposed of before expiry, the reason to be
justified and documented.
• Index of materials retained
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32. What Good Laboratory Must
Contain.?
• Area should be free from smoke, smell, dust etc.
• Ensure good ventilation, proper illumination and prefer natural
light.
• Air conditioned the lab with humidity control.
• Enough space for measuring and testing instrument
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33. • Proper arrangement of testing.
• Take care of all safety points including proper earthing as well
as fire safety.
• Avoid uncleanable spots in floors, walls, ceiling.
• Establish proper areas for storage of incoming samples as well
as test–completed samples.
• Also provide sample collection place as well as packing and
disposal of tested samples. 33

34. Do this for GLP
• Keep the things at its location after use.
• Store heavy things at bottom & if possible on Trollies.
• Give name of location to everything.
• Follow “Everything has the place & Everything at its place” principle.
• Prepare location list & display it.
• Put ladders for things stored on top.
• Identify everything with its name/ purpose.
• Follow “FIFO” to prevent old accumulation for
laboratory chemicals
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35. Benefits of good laboratory
practices.
• It will give better image of company as a Quality producer in
Global market.
• Provide hot tips on analysis of data as well as measure uncertainty
and perfect record keeping.
• Provide guideline for doing testing and measurement in detail
• Provide guidelines and better control for maintenance of instruments,
environment control, preservation of test records etc
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36. GLP IN OUR
COUNTRY
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37. • National GLP-compliance Monitoring Authority was
established by the Department of Science & Technology
• Approval of the Union Cabinet on April 24, 2002
• A provisional member of the OECD for GLP.
• India is an Observer to the OECD’s Working Group on GLP
• The Authority has trained 33 experts in the country as GLP
inspectors
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38. CONCLUSION
GLP is an FDA regulation which is accepted and
approved as international standards by OECD to
avoid the fraud activities of the testing laboratories for
pesticides , pharmaceuticals , food additives , dyes, to
save the human and environmental health and also erect
good international trade and establish good relationship
among the countries
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39. REFERENCE
1) Good Laboratory Practice. By European Chemical Industry
Ecology and Toxicology Centre (ECETOC), Monograph No.
1,Brussels October 1979.
2) Good Laboratory Practice. by G.E. Paget, MTP Press
Limited, Lancaster 1979
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40. THANK YOU…
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