Good Laboratory Practices, Protocol, Contents of protocol, Conduct of a non-clinical laboratory study, Reporting of non-clinical laboratory study results,

1. Sumtted by:
Neha
1784550032
Assignment :-1st
Topic:- Protocol for & conduct of a Non-clinical laboratory
study
Submitted to:
Mohammad khalid
(Assistant Professor)

2. GLP(Good Laboratory Practice)
 GLP is a FDA regulation.
 GLP is a quality system concerned with the
organizational process and the condition under
which non-clinical health and environmental
safety studies are planned , performed ,
monitered , recorded archived and reported.
 GLP is a formal regulation that was created by the
FDA ( United States food and drug administration)
in 1978
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3. Continue……
Good laboratory practice embodies a
set of principle that provides a frame
work within which laboratory studies
are the planned , monitored , archived
and performed.
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4. Protocol
Each study shall have an approved
written protocol that clearly indicates
the objectives and all method for the
conduct of the study.
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5. Contents of protocol
Identification
Title and statement of purpose
Identification of test items
Names and address of the sponsor ,
test facility and test site.
Proposed date
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6. Continue…….
Name of study director and other
personnel.
Justification for selection of the test
system.
Description of the test system.
Experimental design
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7. Conduct of a non-clinical
laboratory study
The non-clinical laboratory study shall
be conducted in accordance with the
protocol.
Information of the specimens should
be present on container to avoid error
in recording and storage of data.
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8. Continue………
All the data generated shall be
recorded directly. Promptly and legibly
by ink.
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9. Reporting of non-clinical
laboratory study results
A final report shall be prepared for the
each nonclinical laboratory study.
Information on sponsor and test
facility.
Experimental starting and completion
dates.
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10. Continue……..
Objectives and procedure stated in
protocol ( including the changes in
protocol).
Description or material and the test
methods.
A quality assurance program statement.
Storage ( specimens, reference, items,
raw data and final report ).
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