Professional Documents
Culture Documents
PRACTICE
PREPARED BY:
Development
Registration
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GOOD LABORATORY PRACTICE
(GLP)
4
WHY GLP WAS
CREATED?
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
assuranc materials
systems
e ,reagents
program
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
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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
4) Personal sanitation and health 13
precautions
TESTING FACILITY
MANAGEMENT
the 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.
1) General facilities:
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.
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F. TEST AND CONTROL ARTICLES
1) Proper storage.
distributed or returned.
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MIXTURE OF ARTICLES WITH CARRIERS
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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
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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
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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