This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP forms part of Good Manufacturing Practices and aims to minimize product failures by avoiding shortcuts. The document outlines the scope of GLP regulations including study types covered and excluded. It also summarizes the key requirements of GLP regulations regarding organization, personnel, facilities, equipment, operations, test articles, protocols, records and reports. Finally, it discusses disqualification of non-compliant testing facilities.

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GOOD LABORATORY PRACTICE [GLP]
SAGAR KISHOR SAVALE
2016 – 017
avengersagar16@gmail.com
INTRODUCTION
• Good Laboratory Practices form a part of Good Manufacturing Practices.
• It is very difficult to separate Good Laboratory Practices from Good Manufacturing
Practices.
• In a manufacturing unit , if the production department strictly follows Good Laboratory
Practices and does not make shortcuts, product failures are minimum.
SCOPE OF GLP
 GLP regulations are issued under the FDA commissions.
 Protocols and SOP’s, adequate facilities and equipment, full identifications of test
substances, proper animal care, equipment maintenance, accurate recording of
observations and accurate reporting of results are basic requirements for the conduct of
a high quality, valid toxicity or any scientific study.
 Any in vivo or in vitro experiment in which a test substance is studied in a test system
under laboratory conditions to determine its safety.
STUDIES WHICH ARE NOT WITHIN THE SCOPE OF GLP REGULATION
 Pharmacological experiments
 Basic research
 Dose-range finding studies
 Studies to develop new methodologies

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 Human or animal efficacy studies
 Chemical assays for quality control of commercial products
 Stability tests on finished dosage forms
 Studies on medical devices that are not implanted in humans
 Chemical and physical tests of radiation products
 Tests conducted for the release of licensed biological products
GLP REGULATIONS
(SUBPART A: GENERAL PROVISIONS)
Study of a product regulated by the FDA
 In vivo or in vitro study
 Study in which the FDA regulated product is administered or added to nonhuman
animals, plants, microorganisms.
 Study results may be used to predict adverse effects of product
SUBPART B (ORGANIZATION AND PERSONNEL)
 Each individual engaged in the conduct of or supervision of a non clinical laboratory
study shall have education, training and experience.
 Each testing facility shall maintain a current summary of training and experience and
job description for each individual engaged in non clinical laboratory study.
SUBPART C (FACILITIES)
 Each testing facility shall be of suitable size and construction to facilitate the proper
conduct of nonclinical lab. Study.
ANIMAL CARE FACILITIES
 A testing facility shall have a sufficient no. of animal rooms or areas as needed
 To ensure isolation of studies being done with test systems or test & control articles.

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ANIMAL SUPPLY FACILITIES
 There shall be storage areas for feed, bedding, supplies and equipment.
 There shall be separate areas for receipt &storage of the test and control articles, mixing
of the test & control articles with a carrier, storage of the test & control articles mixtures.
 Storage areas for control & test articles shall be separate from areas housing the test
systems & shall be adequate to preserve the identity, strength, purity & stability of
articles and mixtures.
SUBPART D: EQUIPMENT
 Equipment Design: Equipment should be of adequate capacity to function & suitably
located for operation, inspection, cleaning & maintenance.
 Maintenance & calibration of equipment, equipment shall be tested, calibrated or
standardized.
 Written records shall be maintained of all inspection, maintenance, testing, calibrating
operations.
SUBPART E: TESTING FACILITIES OPERATION
A testing facility shall have SOP in writing to ensure the quality & integrity of the data
generated in the course of a study.
SOP’S SHALL BE ESTABLISHED FOR
Animal room preparation
Animal care
Receipt, identification, storage, handling, mixing & method of sampling of the test &
control articles
Test system observations
Laboratory tests
Collection & identification of specimens

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Maintenance & calibration of equipment
SUBPART F: TEST AND CONTROL ARTICLE
 The identity, strength, purity &composition shall be determined for each batch & shall
be documented.
 In case of marketed products used as control articles, such products will be
characterized by their labeling.
 The stability of each test or control article shall be determined by testing facility before
study initiation.
 Each storage container shall be labeled by name, batch no. expiration date, storage
conditions.
SUBPART G: PROTOCOL FOR CONDUCT OF A NONCLINICAL LABORATORY
STUDY
 A descriptive title &statement of the purpose of the study.
 Identification of the test &control articles by name, chemical abstract no.
 The name of sponsor &name & address of the testing facility at which the study is being
conducted.
 The number, body wt., sex, source of supply, system.
 The procedure for identification of test system.
 A description of the experimental design, including the methods.
 A description or identification of the diet used in the study as well as solvents,
emulsifiers.
 Each dosage level of the test &control article to be administered & method & frequency
of administration.
 The records to be maintained.
 A statement of the proposed statistical methods to be used.

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SUBPARTS J: RECORDS & REPORTS
A final report shall be prepared for each nonclinical lab. study & shall include,
 Name & add. of the facility performing the study & the dates on which the study was
initiated & completed.
 Objectives & procedures stated in the approved protocol.
 Statistical methods employed for analyzing the data.
 The test &control articles identified by name, chemical abstract no., strength, purity &
composition.
 A description of the methods used.
 A description of the test system used.
 A description of the dosage, dosage regimen, route of administration & duration.
 A description of all circumstances that may have affected the quality of the data.
 The name of study director, the names of supervisory personnel involved in the study.
 A description of the transformation, calculations performed on the data, summary
&analysis of the data, statement of the conclusions drawn from the analysis.
 The signed &dated reports of each of the individual scientists involved in the study.
 The location where all specimens, raw data, & the final reports are to be stored.
 The statement prepared & signed by the quality assurance unit.
SUBPART K: DISQUALIFICATION OF TESTING FACILITIES
 Disqualification is the most severe penalty that FDA can apply for failure to comply
with GLP requirements. If a laboratory is disqualified, the completed or future studies
conducted by that laboratory may not be accepted by FDA in support of an application
for a research.
 The results of a study conducted by a disqualified laboratory may work to the sponsor’s
disadvantage.

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 The FDA has issued many warnings & has rejected individual studies for reasons of
GLP noncompliance.
TEN COMMANDMENTS OF GLP
1. They shall write procedures.
2. They shall follow thy written procedures.
3. They shall correctly document thy work.
4. They shall review and retain thy work.
5. They shall validate their work.
6. They shall be neat and clean in their work.
7. They shall plan & build & procure proper systems facilities and instruments.
8. They shall audit to control systems, facilities & instruments for assessing quality of
products.
9. They shall maintain & improve thy systems, facilities & instruments.
10. They shall be Competent.