Professional Documents
Culture Documents
GLP was first introduced in New Zealand and Denmark in 1972, and
later in the US in 1978 in response to the Industrial Bio Test Labs scandal.
Development
Registration
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Good Laboratory Practice (GLP)
GLP is a formal regulation created by USFDA as these
regulations were proposed on November 19,1976 and designated
as a new part of Chapter 21 of the Code of Federal
Regulations(CFR) as 21 CFR Part 58 in 1979.
In 1981 an organization named OECD(Organization for
Economic Cooperation and Development) produced GLP
principles that are international standards.
GLP in OECD principles is defined as “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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Why GLP was created?
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Replacement of dead animals and fabrication of test results etc.
Advantages of GLP
Assures that the data are a true reflection of results obtained from
studies.
Preclinical safety and residue safety.
Generation of high quality and reliable test data.
Mutual acceptance of data
Increases public confidence.
Shortens the time-to-market for new products.
Disadvantages of GLP
More man power is required.
Expensive process.
Time consuming process. 6
Objectives of GLP
1) GLP makes sure that the data submitted are true reflection of the
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Quality Apparatus,
Test
assurance materials
systems
program ,reagents
Testing
facility Test and
organization reference
and substances
personnel
GLP
Storage Principles
and
Standard
retention
operating
of records
procedures
and
materials
Reporting
of study Performance
of study Facilities
results 8
How to practice GLP?
A. General provisions
B. Organization and Personnel
C. Facilities
D. Equipment
E. Testing facilities operation
F. Test and control articles
G. Protocol for and the conduct of the study
H. Records and Reports
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A. General provisions
regulated by FDA.
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B. Organization and Personnel
1) Organization
2) Personnel
4) Study director
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Organization-Functions
1) Education
2) Training:
a) General training
b) Specific training
3) Experience or combination
study.
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4) Quality assurance program with designated personnel.
Study Director
A scientist or other professional of appropriate education , training
and experience.
Responsibilities of the study director are:
1) Approval of protocol and study plans including amendments.
2) Technical conduct of the study.
3) Ensure that the QA personnel and study personnel are updated
with the study plan and SOPs.
4) Interpretation, analysis, documentation and reporting of the
results.
5) Also checks that experimental data is accurately recorded and
verified.
6) Sign and date the final report for acceptance of data.
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Quality Assurance Unit
1) An individual or a group designated by management to assure
that the studies are in compliance with GLP principles.
b) Archive facilities
c) Waste disposal
3) Animal care
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Standard Operating Procedures (SOPs)
1) Written documents specifying procedures for laboratories
programs.
2) Testing facility should have a written SOP approved by
management.
3) SOPs should be available wherever applicable e.g. test and
reference items, apparatus, materials and reagents, record
keeping, reporting, storage and retrieval, test systems and quality
assurance procedures.
4) Any deviation from SOP should be authorized by SD and
documented in the raw data.
5) Routine inspection, cleaning, maintenance, testing and
calibration.
6) Actions to be taken in response to routine failure. 23
Reagents and solutions
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F. Test and Control Articles
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Test and control article characterization
1) The identity, strength, purity and composition or other
characteristics of test and control article shall be determined and
documented for each batch.
1) Proper storage.
distributed or returned.
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Mixture of articles with carriers
1) Appropriate analytical methods shall be conducted for
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G. Protocol for and conduct of a
nonclinical laboratory study
1) Protocol
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Protocol
Contents of protocol
1.Identification
2.Title and statement of purpose
3.Identification of test(or control) items
4.Names and address of the sponsor, test facility and test site
5.Name of the study director and other personnel
6.Proposed dates
7.Justification for selection of the test system
8.Description of the test system
9. Experimental design 31
Conduct of a nonclinical laboratory study
legibly by ink.
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H. Records and Reports
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Reporting of nonclinical laboratory study results
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References
1.Rang HP. The drug discovery process: general principles and some
case histories. Drug Discovery and Development. 1sted. London:
Elsevier; 2006.p.43
2.Agrawal DK, Arevalo M, Bhalla S, Chai D, Gamaniel KS et al.
Introduction to the WHO/TDR Handbook on GLP. Handbook Good
Laboratory Practice(GLP). 2nded. Switzerland: TDR Publications;
2001.p.1-7
3.Huber L. Introduction to GLP/cGMP basics. A primer Good
laboratory practice and current good manufacturing practice.
Germany: Agilent Technologies; 2000-2002.p.3-31
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Cont.…
4.Seiler JP. Excerpts from the United States food and drug agency
good laboratory practice for nonclinical laboratory studies 21 code
of federal regulations part 58. good laboratory practice-the why and
the how. 2nded. New York: Springer-Verlag berlin Heidelberg;
2005.p.312-328
5.Sharma PP. Practice of GLP. How to practice GLP. 1sted. Delhi:
Vandana publications; 2000.p.214-309
6.Agrawal DK, Arevalo M, Bhalla S, Chai D, Gamaniel KS et al.
Good Laboratory Practice training. Handbook Good Laboratory
Practice(GLP). 2nded. Switzerland: TDR Publications; 2001.p.9-56
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