Good laboratory practice guidelines. GLP IN INDIA.

PRESENTED BY
SELVARAJ.P
PH.D SCHOLAR
OCT-2019 BATCH
GUIDE
DR.SASI.VAITHILINGAN
PROFESSOR CUM VICE-PRINCIPAL
VMCON PONDICHERRY.
SEMINAR ON GOOD LABORATORY
PRACTICE GUIDELINES

INTRODUCTION
• Good Laboratory Practice (GLP) deals with the
organization, process and conditions under which
laboratory studies are planned, performed,
monitored, recorded and reported.
• GLP data are intended to promote the quality and
validity of test data
4/16/2020 VMRF(DU) NSG19OCT07

Con’t
• “If experimental work is conducted in compliance with
GLP, with or without the aid of computer, it should be
possible for an inspector, maybe four or five years
hence, to look at the records of the work and
determine easily why, how and by whom the work was
done, who was in control, what equipment was used,
the results obtained, any problems that were
encountered and how they were overcome”.(Weller)

HISTORY
• The term GLP was first used in New Zealand in
1972.
• GLP was instituted in US following cases of fraud
generated by toxicology labs
• 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.

Con’t
• Assure the quality and integrity of safety
Nonclinical laboratory studies
• In 1981 an organization named OECD
(organization for economic co-operation and
development ) produced GLP principles that are
international standard.

GLP DEFINITION
• 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
• Clinical lab- Human blood test
• Non clinical lab- Just research, not related to
human patients
• GLP refers to a quality system of management
controls for laboratories where research is taking
place, the labs are not treating humans.

PURPOSE OF GLP
1. To promote the development of quality test data
2. Obtain reliable and reproducible data
3. Obtain comparable data between countries
4. Achieve international confidence in study data
5. Avoid repetition of studies
6. Enable reconstruction of studies

Con’t
7. Optimise animal conditions
8. Shorten the registration time of the drug
9. To decrease the occurrence of mistake
10. Limit waste resources
11. Ensure high quality of result
12. Ensure comparability of results
13. Promote mutual recognition of results.

SCOPE
• GLP is a requirement in regulatory non-clinical
safety testing of the following test items :-
1.Pharmaceutical products-
2. Pesticide products-
3. Cosmetic products-
4. Veterinary products-
5. Food additives-4/16/2020 VMRF(DU) NSG19OCT07

Con’t
6. Feed additives
7. Industrial chemicals
8. Repeated dose toxicity (sub-acute and chronic)
9. Reproductive toxicity
10. Mutagenic potential Carcinogenic potential
11. Local tolerance studies

BASICS FUNDAMENTAL POINTS
1. Resources
2. Characterisation
3. Rules
4. Results
5. Quality Assurance

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. Standard Operating Procedures
8. Performance of the Study
9. Reporting of Study Results
10. Storage and Retention of Records and Materials

1.Test Facility Organisation and
Personnel
1.1 Test Facility Management’s Responsibilities
1.2 Study Director’s Responsibilities
1.3. Principal Investigator’s Responsibilities
1.4 Study Personnel’s Responsibilities

1.1.Test Facility Management’s
Responsibilities
• Responsibilities of management
• Sufficient number of qualified personnel, Ensure the
maintenance of a record
• Job description for each professional and technical
individual.
• Documented approval of the study plan by the Study
Director.

1.2 Study Director’s Responsibilities
• Approve the study plan.
• Amendments to the study plan
• Availability of SOPS to the personnel.
• Raw data generated are fully
• Computerised systems used
• Final report
• Ensure that after completion (including termination)

1.3 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.

1.4 Study Personnel’s Responsibilities
• Knowledgeable Instructions Recording
Responsibilities Health precaution
• Access to the study plan and appropriate Standard
Operating Procedures
• Recording raw data
• Health precautions

2. QUALITY ASSURANCE PROGRAMME
1.Quality assurance personnel
2.Study plan contains the information-verification
3.Conduct inspections Study-based inspections
Facility-based inspections Process-based
inspections.
4.Records of such inspections should be retained
5. Prepare and sign a statement,

3. FACILITIES
3.1 General
3.2 Test System Facilities
3.3 Facilities for Handling Test and Reference Items
3.4 Archive Facilities
3.5 Waste Disposal

3.1 General
• The test facility should be of suitable size,
construction and location
• The design of the test facility should provide an
adequate degree of separation of the different
activities to assure the proper conduct of each
study

3.2 Test System Facilities
• Sufficient number of rooms or areas assure the
isolation of test systems and the isolation of
individual
• There should be storage rooms or areas as needed.
• Areas should be available for the diagnosis,
treatment and control of diseases

3.3 Facilities for Handling Test and
Reference Items
• To prevent contamination or mix-ups, there should
be separate rooms
• Storage rooms or areas for the test items should be
separate from rooms or areas containing the test
systems. They should be adequate to preserve
identity, concentration, purity, and stability, and
ensure safe storage for hazardous substances.4/16/2020 VMRF(DU) NSG19OCT07

3.4 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.

3.5 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
• Apparatus, including validated computerised systems,
• Apparatus used in a study should be periodically
inspected,
• Chemicals, reagents, and solutions should be labelled
to indicate identity
• Date and stability should be available.
• The expiry date may be extended on the basis of
documented evaluation or analysis.4/16/2020 VMRF(DU) NSG19OCT07

5. TEST SYSTEMS
5.1 Physical/Chemical
• Physical/chemical data should be suitably
located
• The integrity of the physical/chemical test
systems should be ensured.

5.2 Biological
• Proper conditions should be established and
maintained for the storage
• Newly received animal and plant test systems should
be isolated
• Records of source date of arrival
• Biological test systems should be acclimatised to the
test environment
• Test systems used in field studies should be located so
as to avoid interference4/16/2020 VMRF(DU) NSG19OCT07

6. TEST AND REFERENCE ITEMS
6.1 Receipt, Handling, Sampling and Storage
1. Records including test item and reference item
2. Handling, sampling, and storage procedures should
be identified
3.Storage container(s) should carry identification
information, expiry date, and specific storage
instructions

6.2 Characterisation
• Each test and reference item should be appropriately
identified
• Co-operation between the sponsor and the test facility
• Test item is administered in a vehicle, stability of the
test item in that vehicle should be determined.
• A sample for analytical purposes from each batch of
test item should be retained for all studies except
short-term studies4/16/2020 VMRF(DU) NSG19OCT07

7. STANDARD OPERATING PROCEDURES
1. Test and Reference Items
2. Apparatus, Materials and Reagents
3. Record Keeping, Reporting, Storage, and Retrieval
4. Test System (where appropriate)
5. Quality Assurance Procedures

8. PERFORMANCE OF THE STUDY
8.1 Study Plan
• A written plan should exist prior to the initiation of the study.
• IT should also be approved by management and the sponsor
• Any amendments to the study plan should be justified and
approved.
• Deviations from the study plan should be described,
explained, acknowledged
• For short-term studies a general study plan accompanied by
a study specific supplement may be used.

8.2 Content
1. Identification of the Study, the Test Item and
Reference Item
a). A descriptive title
b). A statement which reveals the nature and purpose
of the study
c) .Identification of the test item by code or named)
the reference item to be used

2. Information Concerning the Sponsor
and the Test Facility
a) Name and address of the sponsor
b) Name and address of the test facilities and test
sites involved
c) Name and address of the study director
d) Name and address of the principal investigator and
the phase delegated by the study director and
under the responsibility of the principal investigator4/16/2020 VMRF(DU) NSG19OCT07

3. Dates
• The date of approval of the study director and by
the management and sponsor and if required by
national regulation /legislation in the country where
the study is being performed.
• The proposed experimental starting and completion
dates.

4. Test Methods
• Reference to the OECD Test Guideline or other test
guideline or method to be used.
5. Issues
a) The justification for selection of the test system;
b) Characterisation of the test system
c) The method of administration and the reason for its
choice
e) Detailed information on the experimental design,4/16/2020 VMRF(DU) NSG19OCT07

8.3 Conduct of the Study
• A unique identification should be given to each study
• The study should be conducted in accordance with the
study plan
• All data generated during the conduct of the study
should be recorded directly
• computerised system design should provide for the
retention of full audit trials to show the changes in the
data without obscuring the original data4/16/2020 VMRF(DU) NSG19OCT07

9. REPORTING OF STUDY RESULTS
9.1 General
1. A final report should be prepared for each study
2. Reports of Principal Investigators
3.The final report should be signed and dated by the
Study Director
4. Corrections and additions to a final report should be in
the form of amendments
5.Reformatting of the final report to comply with the
submission requirements

9.2 Content of the Final Report
1. Identification of the Study, the Test Item and Reference
Item
2. Information Concerning the Sponsor and the Test Facility
3. Dates
4. Statement
5. Description of Materials and Test Methods
6. Results
7. Storage

10. STORAGE AND RETENTION OF
RECORDS AND MATERIALS
• 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
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.4/16/2020 VMRF(DU) NSG19OCT07

GLP IN INDIA
• 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.4/16/2020 VMRF(DU) NSG19OCT07

CONCLUSION
• GLP is an FDA regulation which is accepted
and approved as international standards by
OECD to avoid the fraud activities of the
testing laboratories
• Every one makes mistake that's why GLP
needed

9. REFERENCE
1. OECD Principles of Good Laboratory Practice (as revised in
1997), ENV/MC/CHEM(98)17, OECD, Paris, 1998. (No.1 in
OECD Series on Good Laboratory Practice and Compliance
Monitoring)
2. https://www.who.int/tdr/publications/documents/glp-
handbook.pdf
3. OECD PRINCIPLES AND GUIDANCE FOR MONITORING – ISBN
92-64-01282-6 – © OECD 2005. Good Laboratory Practice
Regulations Fourth Edition edited by Sandy Weinberg.
Handbook: good laboratory practice (GLP): quality practices
for regulated non-clinical research and development - 2nd
edition. P.P. Sharma “how to practice GLP” vandana
publication. 42
4. https://en.wikipedia.org/wiki/Good_laboratory_practice

Good laboratory practice guidelines. GLP IN INDIA.

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Good laboratory practice guidelines. GLP IN INDIA.