The document outlines the protocol for conducting non-clinical laboratory studies under Good Laboratory Practice (GLP), a regulatory framework established by the FDA in 1978. It details the necessary components of study protocols, including objectives, test items, and personnel, as well as procedures for data collection and reporting results. The final report must include comprehensive information about the study, ensuring proper documentation and quality assurance.

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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