Good Laboratory Practice

(GLP)

By Nadhra
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 AGENDA
09.00 – 09.30 am : Introduction & Fundamentals of GLP
09.30 – 10.00 am : Principles & Basic Points of GLP
10.00 – 10.15 am : Morning Break
10.15 – 10. 30 am : Test Facility, Organization &
Personnel
10.30 – 11.00 am : Quality Assurance Program
11.00 – 11.30 am : Facilities
11.30 – 12.00 pm : Apparatus, Material and Reagents
12.00 – 12.30 pm : Test Systems
12.30 – 01.30 pm : Lunch

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 AGENDA
01.30 – 02.00 pm : Test and Reference Items
02.00 – 02.30 pm : Standard Operating Procedure
02.30 – 03.00 pm : Performance of the Study
03.00 – 03.15 pm : Tea Break
03.15 – 03.45pm : Reporting Study Results
03.45 – 04.15 pm : Storage and Retention of Records
and Materials
04.15 – 04.45 pm : Q&A and Review
04.45 – 05.00 pm : Reflections

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 OBJECTIVE :

1) xxxxx

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 REFERENCE
● OECD Principles on Good Laboratory
Practice
● WHO Handbook Good Laboratory Practice
(GLP)

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 INTRODUCTION OF GLP
The Birth of GLP
● In the early 1970s, the FDA investigated
a number of cases of poor practice in
toxicology laboratories throughout the
USA
● Results of this investigation in about 40
laboratories revealed many cases of
poorly managed studies, insufficient
training of personnel, and some cases of
deliberate fraud
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 INTRODUCTION OF GLP
FDA Investigation Findings
● Poorly-trained Study Directors and study
personnel
● Poorly-designed protocols
● Protocols not followed - procedures not
conducted as prescribed
● Raw data badly collected - not correctly
identified -without traceability - not
verified or approved by responsible
persons
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 INTRODUCTION OF GLP
FDA Investigation Findings
● Inadequate characterization of test items
and test systems
● Inadequate resources
● Equipment not properly calibrated or
otherwise qualified
● Reports not sufficiently verified,
inaccurate account of study or raw data
● Inadequate archives and retrieval
processes 8
 INTRODUCTION OF GLP
FDA Decision
● Introduce a new regulation to cover NON-
CLINICAL SAFETY STUDIES
● Good Laboratory Practice regulations
– Draft USA GLP in 1976
– An enforceable USA regulation in 1979
● Recommended for use in OECD Member
countries by the OECD Council in 1981

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FUNDAMENTALS OF GLP

GLP

Promotes

Quality and Validity of Data

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 FUNDAMENTALS OF GLP

To help scientists obtain results that are:

• Reliable
• Repeatable
• Auditable
• Recognized by scientists worldwide

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