A detailed description on GLP and all the subparts included in it. knowledge on all laboratory practices.

1. GOOD LABORATORY PRACTICES(GLP)
Prepared by,
Reecha shah

2. INTRODUCTION:
Why GLP?
In the early 70’s USFDA found out dishonest activities and poor laboratory practices throughout
the United States.
 So , they decided to start inspections in depth and check over 40 toxicological labs
Examples of some of these poor lab practices found were equipment not been
calibrated to standard form, therefore giving wrong measurements, incorrect or inaccurate
accounts of the actual lab study and incompetent test systems.
 Although the term “good laboratory practice” might have been used informal already for some
time in many laboratories around the world GLP originated in the United States and it had a
powerful effect world wide.

3. Formation and History of GLP:
 GLP is officially formed by FDA in 1978
The OECD (Organization for Economic Co-operation and Development) Principles of Good
Laboratory Practice were first created by an Expert Group on GLP set up in 1978 under the Special
Programme on the Control of Chemicals.
 It was guided by the United States and consisted experts from the following countries and
organizations as Belgium , Canada , japan , Italy , Russia , Sweden , Switzerland , the united
kingdom and the international organization of standardization, Norway , New Zealand ,
Netherlands.
 A set of the principles were made under GLP which were followed by these member countries
created by the OECD council.
.

4. Definition :
• According to OECD,
• Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and
the conditions under which non-clinical health and environmental safety studies are planned,
performed, monitored, recorded, archived and reported.
• GLP describes good practices for non-clinical lab studies that support research or marketing
approvals for FDA-regulated products

5. Purpose:
• The principles of good laboratory practice (GLP) is to support the development of quality and
validity of test data used for determining the safety of chemicals and chemicals product.
• It mainly aims to decrease the mistakes or mix ups
• To promote the duality of test data
• To avoid duplication of work
• To improve the protection of public health
• To facilitate the international acceptance of test data
• To prevent the technical trade barriers

6. Principles of GLP:

7. Benefits:
• It will give better image of company as a quality producer in global market
• Helps in record keeping and documentation
• Provides guidelines for doing testing
• Maintenance of instruments and preservation of test records.

8. USFDA GLP regulations (subpart A-subpart K)
Code of Federal Regulations Title 21 Foods and Drugs
PART 58 GOOD LAORATORY PRACTICE FOR NON CLINICAL STUDIES
SUBPART A- GENERAL PROVISIONS
a. Scope – This parts prescribes GLP for conducting non clinical laboratory studies that support applications for
research or marketing permits products regulated by the FDA including drugs ,food and color.
b. Definitions.
c. Applicability to studies performed under grants and contracts-when a sponsor conducting a non clinical laboratory
study intended to be received and submitted to and by the FDA and it shall notify the consulting laboratory that the
study is a part of non clinical laboratory study under compliance.
d. Inspection of a testing facility-it permits authorized person of FDA to inspect the facility and records and
specimens.
SUBPART B-ORGANIZATION AND PERSONNEL
a. Personnel-should have education , experience , sufficient in number and understanding functions.
b. Testing facility management-Assure that personnel, resources, facilities, equipment, materials, and methodologies
are available as scheduled.

9. c. Study director-A scientist with appropriate education and training experience and does interpretation ,
documentation .
d. QA unit-inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study
and maintain written and properly signed records of each periodic inspection showing the date of the
inspection, the study inspected, the phase or segment of the study inspected, the person performing the
inspection, findings and problems, action recommended and taken to resolve existing problems, and any
scheduled date for reinspection . Any problems found during the course of an inspection which are likely to
affect study integrity shall be brought to the attention of the study director and management immediately
SUBPART C-FACILITIES
a. General-shall be of suitable size and construction
b. Animal care facilities-separation of species/test systems . Isolation of individual projects , quarantine of
animals and housing of animals. Separate areas for diagnosis and treatment etc.
c. Animal supply facilities-with bedding , storage , feed and protections.
d. Facilities for handling test and control articles
e. Laboratory operation areas
f. Specimen and data storage facilities-documented by authorized personnel

10. SUBPART D- EUIPMENT
a. Equipment design-equipment used in the generation , measurement or assessment of data used for facility
environmental control shall be of appropriate design and adequate capacity to function according to the
protocol and shall be located for operation , inspection , cleaning and maintenance.
b. Maintenance and calibration of equipment-adequately , inspected , cleaned and maintained
Working according to SOP’s
Under authorized personnel
Written records should be maintained
SUBPART E-TESTING FACILITIES OPERATION
a. SOP-A testing facility shall have standard SOP in writing setting forth study methods that management is
satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. For
e.g. animal care , data storage , handling etc.
b. Reagents and solutions-should be properly labelled , stored and not outdated.
c. Animal care

11. SUBPART F- TEST AND CONTROLARTICLES
a. Test and control article characterization-The identity, strength, purity, and composition or other
characteristics which will appropriately define the test or control article shall be determined for each batch
and shall be documented .The stability of each test or control article shall be determined by the testing
facility or by the sponsor either and the storage container in which it is filled should e labeled properly.
b. Test and control article handling-there should be a proper storage ,proper distribution process to avoid
contamination, throughout identification during distribution process and documentation.
c. Mixtures of articles with carriers- each test or control article that is mixed with a carrier, tests by appropriate
analytical methods shall be conducted:
(1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test or
control article in the mixture.
(2) To determine the stability of the test and control articles in the mixture as required by the conditions of the
study either

12. SUBPART G- PROTOCOL FOR CONDUCT OF A NON CLINICAL LABORATORY STUDY
a. Protocol-each study shall have an approved written protocol that clearly indicates the objectives and all
methods foe the conduct of the study. A descriptive title and statement of the purpose of the study.
Identification of the test and control articles by name, chemical abstract number, or code number The name
of the sponsor and the name and address of the testing facility at which the study is being conducted.The
number, body weight range, sex, source of supply, species, strain, sub strain, and age of the test system The
procedure for identification of the test system. A description of the experimental design, including the
methods for the control of bias.
b. Conduct of a non clinical laboratory study-in accordance with the protocol .
SUBPART H-I [RESERVED]
SUBPART J-RECORDS AND REPORTS
a. Reporting of non clinical laboratory study results
b. Storage and retrieval of records and data
c. Retention of records

13. SUBPART K-DISQUALIFICATION OF TESTING FACILITIES
a. Purpose-To permit the exclusion from consideration of completed studies that were conducted by a testing facility
which has failed to comply with the requirements of the good laboratory practice regulations until it can be
adequately demonstrated that such noncompliance did not occur during, or did not affect the validity or
acceptability of data generated by, a particular study
b. Grounds of disqualification
c. Notice of and opportunity for hearing on proposed disqualification.
d. Final order on disqualification.
e. Actions upon disqualification.-Once a testing facility has been disqualified, each application for a research or
marketing permit, whether approved or not, containing or relying upon any nonclinical laboratory study conducted
by the disqualified testing facility may be examined to determine whether such study was or would be essential to a
decision. If it is determined that a study was or would be essential, the Food and Drug Administration shall also
determine whether the study is acceptable, notwithstanding the disqualification of the facility. Any study done by a
testing facility before or after disqualification may be presumed to be unacceptable, and the person relying on the
study may be required to establish that the study was not affected by the circumstances that led to the
disqualification, e.g., by submitting validating information. If the study is then determined to be unacceptable, such
data will be eliminated from consideration in support of the application; and such elimination may serve as new
information justifying the termination or withdrawal of approval of the application.

14. f. Public disclosure of information regarding disqualification.-disclosable to the public under part 20 of this
chapter.
g. Alternative or additional actions to disqualification.
h. Suspension or termination of a testing facility by a sponsor
i. Reinstatement of a disqualified testing facility-A testing facility that has been disqualified may be reinstated
as an acceptable source of nonclinical laboratory studies to be submitted to the Food and Drug
Administration if the Commissioner determines, upon an evaluation of the submission of the testing facility,
that the facility can adequately assure that it will conduct future nonclinical laboratory studies in compliance
with the good laboratory practice regulations set forth in this part.

15. Summarized process

16. Ensure that all the
personnel
working are
according to
protocols
Ensure that all the
facilities is of
suitable size and
proper location
Ensure that
equipments are
properly workings
and reagents
stored and
labelled properly
Set of approved
and revised SOP’s
are present
no
yes
Provide
training
No
disqualification
no
yes
arrange the proper
facilities per guidelines
No
disqualification
yes
no
no
yes
No
disqualification
Labels reagents
properly
No
disqualification
Make it available
and document
accordingly

17. References:
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
• GLP: Good Laboratory Practice Isin Akyar Acibadem University Faculty of Medicine Department
of Medical Microbiology Turkey