1a - GLP

Good Laboratory Practice (GLP)
A quality system concerned with the organizational

process and the conditions under which
laboratory studies are planned, performed,
monitored, recorded, archived and reported.
GLP covers the whole range of Laboratory Processes

History/why was GLP created?
GLP was instituted in US following cases of fraud generated by toxicology
labs in data submitted to the FDA by pharmaceutical companies.
Industrial Bio Test Lab (IBT) was the most notable case, where thousands
of safety tests for chemical manufacturers were falsely claimed to have
been performed or were so poor.
 First introduced in New Zealand in 1972.
 FDA promulgated the Good Laboratory Practice (GLP) Regulations, on
December 22, 1978. The regulations became effective June 1979.
 In 1981 Organization for Economic Co-operation & Development
(OECD) produced GLP principles which were accepted in all other
OECD Member Countries and are in practice.
Objectives of GLP
 To makes sure that the data submitted are a true reflection of the
results that are obtained during the study.
 To makes sure that not to indulge in any fraud activity by labs.
 To promote international acceptance of tests / Data thus

generated .
Purpo
se
 Ensure quality test data
 Ensure sound laboratory management
 Ensure robust conductance of laboratory testing
 Ensure accurate reporting of test findings
 Ensure safe archival of laboratory data

Main Focus of GLP
Whatever the industry targeted, GLP stresses the importance of the
following main points:
1. Resources: Organization, personnel, facilities and equipment;
2. Characterization: Test items and test systems;
3. Rules: Protocols, standard operating procedures (SOPs);
4. Results: Raw data, final report and archives;
5. Quality Assurance: Independent monitoring of research processes.

1. Resources: Organization, personnel,
facilities and equipment;
 Services of sufficient relevant professional shall be available with
defined jobs and responsibilities
 Sufficient number of rooms or areas assure the isolation of test
systems and the isolation of individual projects involving
substances or organisms known to be or suspected of being
biohazardous with biohazard auto detect and control system
(where applicable).
 There should be storage rooms or areas as needed for supplies and
equipment.
 Archive facilities should be provided for the secure storage and
retrieval of study plans, raw data, final reports, samples of test
items and specimens. Archive design and archive conditions should
protect contents from untimely deterioration.
 Handling and disposal of wastes should be carried out in such a way
as not to jeopardies the integrity of studies. This includes provision
for appropriate collection, storage and disposal facilities, and
decontamination and transportation procedures
 Apparatus, including validated computerized systems, used for the
generation, storage and retrieval of data, and for controlling
environmental factors relevant to the study.
 Apparatus used in a study should be periodically inspected, cleaned,
maintained, and calibrated according to Standard Operating Procedures.
 Apparatus and materials used in a study should not interfere adversely
with the test systems.
 Chemicals, reagents, and solutions should be labelled to indicate
identity(with concentration if appropriate), expiry date and specific
storage instructions. Information concerning source, preparation date
and stability should be available. The expiry date may be extended on
the basis of documented evaluation or analysis.
2. Characterization: Test items and
test systems;
Drug Product
 Test item-product going to be
tested
 identity, impurity
Toxicity Testing QC Testing and Analysis profile, potency,
solubility, composition,
stability, chemical
Characterization nature.
 new formula or
modified
 previous product
formula
Release to the market Results submitted to  Test system-to which animal is
& mass produced regulatory agency
going to be administered
3. Rules: Protocols, standard operating procedures (SOPs);
1. Study Plan
Content of the Study Plan:
i. Dates
ii. Test Methods (Description of Materials and Test Methods)
iii. Issues (where applicable)
iv. Records.
v. A list of records to be retained
vi. Conduct of the Study.
4. Results: Raw data, final
report and archives;
Content of the Final Report:
i. Identification of the Study, the Test Item and Reference Item
ii. Information Concerning the Sponsor and the Test Facility
iii. Dates
iv. Statement
v. Description of Materials and Test Methods
vi. Results
vii. Storage
5. Quality Assurance: Independent monitoring of
research processes.
 The study plan, raw data, samples of test and reference items,
specimens and the final report of each study.
 Records of all inspections performed by the Quality Assurance
Program, as well as master schedules.
 Records of qualifications, training, experience and job descriptions
of personnel.
 Records and reports of the maintenance and calibration of
apparatus.
 Validation documentation for computerized systems.
GLP in Pharmaceutical Industry
 GLP from a Quality System perspective

 GLP from a Regulatory perspective
GLP AT GLANCE
Product Development / Manufacturing
Audit Inspections
Non-clinical &
Regulatory Body
Environmental Clinical
Study; GLP Corporate Audit
Inter departmental Audit
Intra-Departmental Audit
Data submitted to Release to market

Regulatory Agency

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Good Laboratory Practice (GLP)

A quality system concerned with the organizational

GLP covers the whole range of Laboratory Processes

 To makes sure that not to indulge in any fraud activity by labs.

 To promote international acceptance of tests / Data thus

 Ensure sound laboratory management

 Ensure robust conductance of laboratory testing

 Ensure accurate reporting of test findings

 Ensure safe archival of laboratory data

1. Resources: Organization, personnel, facilities and equipment;

2. Characterization: Test items and test systems;

3. Rules: Protocols, standard operating procedures (SOPs);

4. Results: Raw data, final report and archives;

5. Quality Assurance: Independent monitoring of research processes.

 GLP from a Quality System perspective

Inter departmental Audit

Data submitted to Release to market

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