history and importance of good laboratory practices

1. GOOD LABORATORY
PRACTICES
DINESH K
M. PHARM PHARMACOLOGY
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2. CONTENS
• INTRODUCTION
• OCED
• PRINCIPLES OF OCED-GLP
• GOOD LABORATORY PRACTICES
• HISTORY OF GLP
• OBJECTIVES OF GLP
• MISSION OF GLP
• SCOPE OF GLP
• PERSONEL IN GLP
• IMPORTANCE
• REFERENCE
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3. OECD
• An intergovernmental organisation.
• Representatives of 30 industrialised 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.
• Environmental Health and Safety Division.
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4. PRINCIPLES OF OCED-GLP
•
• The Principles of GOOD LABORATORY PRACTICES are a managerial
quality control system covering the organisational process and the
conditions under which non-clinical health and environmental studies
are planned, performed, monitored, recorded, reported and retained
(or archived). The OECD Principles of GLP are followed by test facilities
carrying out studies to be submitted to receiving authorities for the
purposes of assessing the health and environmental safety of
chemicals and chemical products which may also be of natural or
biological origin and, in some circumstances, may be living organisms.
• The Principles of GLP define the responsibilities of test facility
management, study director, study personnel and quality assurance
personnel that are operating within a GLP system, and minimum
standards concerning the suitability of facilities and equipment to
perform studies, the need for standard operating procedures,
documentation of raw data, study reports, the archiving of records,
etc
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5. • Good Laboratory Practice (GLP) is a quality system
concerned with the organisational process and the
conditions under which non-clinical health and
environmental safety studies are planned,
performed, monitored, recorded, archived and
reported.
INTRODUCTION
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6. HISTORY
The GLP regulations
for non-clinical
laboratory studies
published by the
US-FDA in 1976
(Baldeshwiler,
2003).
1976
Expert Group was
established in 1995
to develop a
proposal to revise
the Principles of
GLP.
1995
The OECD Principles of
GLP were first
developed by an Expert
Group on GLP
established in 1978
under the Special
Programme on the
Control of Chemicals
1978
The Revised OECD
Principles of GLP were
reviewed in the relevant
policy bodies of the
Organisation and were
adopted by Council on
26 November, 1997.
1997
Principles of GLP
were adopted by the
OECD in 1981.
1981
Indian GLP
Compliance
Monitoring
Authority - April,
2002.
2002 6

7. WHY WAS IT CREATED?
• In the early 70’s FDA became aware of cases of
poor laboratory practice all over the United States.
• FDA decided to do an in-depth investigation on 40
toxicology labs.
• They discovered a lot fraudulent activities and a lot
of poor lab practices.
Examples of some of these poor lab practices found
were
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
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8. OBJECTIVES
 GLP makes sure that the data submitted
are a true reflection of the results that are
obtained during the study.
 GLP also makes sure that data is
traceable.
 Promotes international acceptance of tests
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9. MISSION
Test systems
 Archiving of records and materials.
 Apparatus, material and reagent facilities.
 Quality assurance programs.
 Performance of the study.
 Reporting of study results.
 Standard operating procedures (SOP)
 Personnel and test facility organization
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10. SCOPE
• Principles of GLP should be applied to the non-
clinical safety testing of test items contained in,
Pharmaceutical products
Pesticide products
Cosmetic products
Veterinary drugs
Food and feed additives
Industrial chemicals.
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11. KEY PERSONAL IN GLP
TEST FACILITY MANAGEMENT
STUDY DIRECTOR
PRINCIPLE INVESTIGATOR
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12. QUALITY ASSURANCE STAFF
ARCHIVIST
SPONCER
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13. STANDARD OPERATING
PROCEDURES.
• A test facility should have written SOPs approved by test
facility management.
• Language interpretable to those who are going to use
them.
• Documented procedures which describe how to perform
tests or activities normally not specified in detail in study
plans or test guidelines.
• Deviations from SOPs should be documented and
acknowledged by the SD or the Principal Investigator.
• Published text books, analytical methods, articles and
manuals -supplements to the SOPs.
• Reviewed regularly.
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14. SOPs should be available for the following categories of
activities:
 Test and Reference Items
Apparatus, Materials and Reagents
Record Keeping, Reporting, Storage, and Retrieval
Test System
Quality Assurance Procedures.
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15. IMPORTANCE
• Since raw materials, packaging materials ,
intermediates and finished products are ultimately
released based on the analytical results generated
in the Q.C laboratory.
• Accuracy, precision and reliability of these results
are paramount importance.
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16. CONCLUSION
 The purpose of GLP is to assure the quality and integrity
of data submitted in support of the safety of regulated
products.
 Protocols, SOPs, adequate facilities, and equipment's,
identification of test substance, proper animal care,
accurate recording of observations and adequate reporting
of results are basic necessities for the conduct of high
quality valid toxicity study.
Test results obtained in compliance with GLP are to be
mutually accepted by the health authorities and
environment authorities of the OECD member states.
Therefore, multiple testing can be avoided.
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17. REFERNCES
https://www.oecd.org/chemicalsafety/testing/overview-of-
good-laboratory-practice.htm
Slide shares
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18. Remember…
Safety First!
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