Glp

1. GOOD LABORATORY PRACTICE
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.
HISTORY
In the early 70’s FDA became aware of cases of poor laboratory practice all over the United
States. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of
some of these poor lab practices found were : 1. Equipment not been calibrated to standard
form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual
lab study. 3. Inadequate test systems.
GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in
1978 in response to the Industrial Bio Test Labs scandal
GLP was instituted in US following cases of fraud generated by toxicology labs in data
submitted to the FDA by pharmaceutical companies. As a result of these findings, FDA
promulgated the Good Laboratory Practice (GLP) Regulations, 21 CFR part 58, on
December 22, 1978 (43 FR 59986). The regulations became effective June 1979.
As a international standard: In 1981 an organization named OECD (organization for
economic co-operation and development ) produced GLP principles that are
international standard. of the OECD Council, data generated in the testing of chemicals in
one OECD Member Country, in accordance with OECD Test Guidelines and the Principles
of GLP are accepted in all other OECD Member Countries.
OBJECTIVES OF GLP
 GLP makes sure that the data submitted are a true reflection of the results that are
obtained during the study.
 GLP also makes sure that not to indulge in any fraud activity by labs.
 Promotes international acceptance of tests.
GOOD LABORATORY PRACTICE - PRINCIPLES
1. Test Facility Organisation and Personnel
2. Quality Assurance Programme
3. Facilities
4. Apparatus, Material, and Reagents
5. Test Systems
6. Test and Reference Items
7. Performance of the Study
8. Reporting of Study Results
9. Storage and Retention of Records and Materials

2. 1. Test Facility Organisation and Personnel
a. Test Facility Management’s Responsibilities
b. Study Director’s Responsibilities
c. Principal Investigator’s Responsibilities
d. Study Personnel’s Responsibilities
a. Test Facility Management’s Responsibilities.
 Responsibilities of management as defined by these principles of good laboratory
practice.
 Sufficient number of qualified personnel, appropriate facilities, equipment, and
materials are available for the timely and proper conduct of the Study
 Ensure the maintenance of a record of the qualifications, training, experience.
 Job description for each professional and technical individual.
 Documented approval of the study plan by the Study Director.
b.Study Director’s Responsibilities.
 Approve the study plan.
 Any amendments to the study plan by dated signature.
 Availability of sops to the personnel.
 Raw data generated are fully documented and recorded.
 Computerised systems used in the study have been validated.
 Sign and date the final report to indicate acceptance of responsibility for the validity
of the data.
 Ensure that after completion (including termination) of the study, the study plan,the
final report, raw data and supporting material are archived.
c.Principal Investigator’s Responsibilities
 The Principal Investigator will ensure that the delegated phases of the study are
conducted in accordance with the applicable Principles of Good Laboratory Practice
 Knowledgeable Instructions Recording Responsibilities Health precautions.
d. Study Personnel’s Responsibilities
 personnel should exercise safe woking practices. chemical handle with caution.
 personnel should exercise health precautions to minimise risk to themselves and to
ensure integrity of study.
2. Quality Assurance Programme
The test facility should have a documented QA programme to ensure that studies perfomed
are in compliance with principles of GLP. Individuals should report any finding in written to
study director.
Responsibility of Quality assurance personnel

3.  Ascertain that study plan and SOP are available to personnel conducting the study.
 Ensure that study plan and SOP are followed by periodic inspections of test facility.
 conduct inspections : Study-based inspections Facility-based inspections Process-
based inspections.
 Records of such inspections should be retained.
3.Facilities
a.Test system facilities
 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.
 There should be storage rooms or areas as needed for supplies and equipment.
 Areas should be available for the diagnosis, treatment and control of diseases, in order
to ensure that there is no unacceptable degree of deterioration of test systems.
b. Facilities for handling Test and Reference substances
To prevent contamination and mix-ups there should be separate areas for receipt and
storage of test and reference substances.storage areas should preserve identity,
concentration, purity and stability.
c.Archive Facilities
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.
d.waste disposal
Handling and disposal of wastes should be carried out in such a way as not to jeopardise the
integrity of studies. This includes provision for appropriate collection, storage and disposal
facilities, and decontamination and transportation procedures.
4. Apparatus, Material, and Reagents
a. Apparatus
 Apparatus, used for the generation, storage and retrieval of data, and for controlling
environmental factors relevant to the study should be suitably located and of
appropriate design and adequate capacity.
 Apparatus used in a study should be periodically inspected, cleaned, maintained, and
calibrated according to Standard Operating Procedures. Records of procedures should
be maintained.
b.Materials : Apparatus and materials used in a study should not interfere adversely with the
test systems.

4. c. Reagents :
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.
5. TEST SYSTEM
a. Physical/chemical:
 Apparatus used for generation of Physical/chemical data should be suitably located
and of appropriate design and adequate capacity.
 Reference substances shouls be used to assist in ensuring the integrity of
physical/chemical test systems.
b.biological
 Proper conditioned should be established and maintained for the housing,
handling and care of animals, plants, microbial and cellular and sub cellular
systems.
 Conditions should comply with national regulatory requirements for import,
collection, care and use of animals.
 The diagnosis and treatment of any disease before or during a study should be
recorded.
6. TEST AND REFERENCE SUBSTANCES
a. Receipt, handling, sampling and storage
 Records including substances characterization, date of receipt, quantities
received and used in studies should be maintained.
 Handling, sampling and storage procedures should be identified to assure
homogeneity and stability.
B.Characterization:
 Each test and reference substances should be appropriately identified.
 For each study the identity, including batch number, purity, composition,
concentrations or other characterization to define each batch of test or
reference substance should be known.
 The stability of test or reference substance should be known.
7. STANDARD OPERATING PROCEDURES
A. GENERAL
 A Test facility should have written standard operating procedures
approved by management that are intended to ensure the quality and
integrity of data generated in the course of the study.
 Each separate laboratory unit should have immediately available standard
operating procedures relevant to activities being performed therein.

5. 8. Performance of the Study
a) Study Plan
 For each study , a plan should exist in a written form prior to initiation of the
study.
 The study plan should be retained as raw data.
 All changes, modification or revision in the plan as agreed by study director,
including justification should be documented , signed and dated by study
director and maintained with the study plan.
b) Content of the Study Plan
i. Identification of study, test and reference substances
 A descriptive title
 A statement that reveals nature and purpose of study.
 Identification of test substance by code or name ( IUPAC, CAS
number)
 The reference substance to be used
ii. Information concerning the sponsor and the test facility
 Name and address of the sponsor
 Name and address of the test facility
 Name and address of the study director
iii. Dates
 The date of agreement to the study plan by signature of study director.
 The proposed starting and completion date.
iv. Test Methods
v. Issues (where applicable)
vi. Records.: A list of records to be retained.
c. Conduct of the Study.
 Unique identification given to each study.
 The study should be conducted in accordance with the study plan.
 All data generated should be recorded directly.
9.Reporting of Study Results
Content of the Final Report
 Identification of the Study, the Test Item and Reference Item
 Information Concerning the Sponsor and the Test Facility
 Dates
 Statement
 Description of Materials and Test Methods
 Results
 Storage
10. Storage and Retention of Records and Materials

6. i. Storage and Retrieval: archives should be designed and equipped for
accommodation and secure storage of-
 The study plan,
 raw data
 samples of test and reference items,
 specimens and the final report of each study.
ii. Retention: the following should be retained for the period specified by
authorities
 Records of all inspections performed by the Quality Assurance
Programme, 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 computerised systems.
INDIA GLP IN OUR COUNTRY
 National GLP-compliance Monitoring Authority was established by the
Department of Science & Technology
 approval of the Union Cabinet on April 24, 2002
 A provisional member of the OECD for GLP.
 India is an Observer to the OECD’s Working Group on GLP
 The Authority has trained 33 experts in the country as GLP inspectors.
GLP-COMPLIANCE CERTIFICATION :
o The test facilities/laboratories have to apply in the prescribed application form
GLP-compliance Certification is valid for a period of three years.
o The report, prepared by the inspection team, is put to the Technical Committee
for recommendation to Chairman, National GLP- Compliance Monitoring
Authority.
o After the application for GLP certification is received, a pre-inspection of the
laboratory is carried out by the GLP inspectors, followed by a final inspection.