Good Laboratory Practice

This presentation describes GLP in a nutshell and its implementation in India.

1. Dr. Kaushik Mukhopadhyay
Pharmacology, Final year PGT
IPGME&R

2. 2
GLP
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.
(OECD, 1997)
What is GLP?
Adamo JE et al. A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.
Acad Med. 2012 Mar;87(3):279–84.

3. 3
GLP
Historical Background

4. 4
GLP
GLP TIMELINE
1972
GLP was first introduced in New Zealand Early 1970s
Industrial Bio Test Lab
case was most notable
FDA became aware of
cases of poor laboratory
practice all over the US
decided to do an in-depth
Investigation on 40
toxicology labs.
1978
21 CFR, Part 58
FDA promulgated the
Good Laboratory Practice
(GLP) Regulations

5. 5
GLP
National GLP-compliance Monitoring Authority 
was established by the Department of Science & Technology
1981
An organization named
OECD produced GLP
principles that are
international standard
International Standard
2002
2011
India becomes full-
member for Mutual
Acceptance of Data
(MAD) in the OECD's
Working Group on GLP

6. 6
GLP
Objectives of GLP
True reflection Ensure Honesty
International acceptance
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

7. 7
GLP
Scope of GLP (OECD)
Principles of GLP apply to all non-clinical health and
environmental safety studies required by regulations for
the purpose of registering or licensing -
Pharmaceuticals
Pesticides
Food and feed additives
Cosmetic products
Veterinary drug products and similar products
Industrial chemicals

8. 8
GLP
GLP Principles

9. 9
GLP
GLP Principles
01 02 03 04
08 07 06 05
Test Facility
Organisation
and
Personnel
Quality
Assurance
Programme
Facilities Apparatus,
Material &
Reagents
Reporting of
Study Results
Performance
of the Study
Test and
Reference
Items & SOP
Test
Systems
09
Storage and
Retention of
Records and
Materials

10. 10
GLP
Organisation & Personnel – Management’s Responsibilities
Ensure sufficient number of qualified personnel, appropriate
facilities, equipment, and materials
Ensure the maintenance of a record of the qualifications, training,
experience.
Proper training of personnel to assigned functions
Job description for each professional and technical individual.
To establish and follow SOP
Quality assurance program with designated personnel

11. 11
GLP
Organisation & Personnel – Study Director’s responsibilities
Approval of protocols & the study plan including amendments
Ensure QA personnel and study personnel are updated with study
plans & SOP
Ensure the follow up of SOPs periodically and take appropriate
corrective action
Archiving Raw data, supporting materials and final report.
The individual responsible for the overall conduct of
the non-clinical health and environmental safety
study

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GLP
Organisation & Personnel
Ensures the study is conducted in
accordance with GLP
Recording of all raw data in compliance
with the principles of GLP
Deviations from the instructions to be
reported the PI or SD
Takes health precautions and personal
safety
Study Personnel’s Responsibilities
Principal Investigator’s Responsibilities

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GLP
Quality Assurance Programme
Maintains copies of protocols & SOPs
Inspects each laboratories and man at work –
Study-based inspections
Facility-based inspections
Process- based inspections
Determines any deviation from approved protocol and report to SD, PI &
management
Prepare a statements to be included in final report containing dates & types of
inspection
An individual or a group designated
by management to assure studies are
in compliance with GLP Principles

14. 14
GLP
Facilities
Test System Facilities
Sufficient amount of rooms and areas to assure isolation of test systems
Adequately protected storage area separate from test systems
Areas available for the diagnosis, treatment and control of diseases
Archive facilities
Secure storage and retrieval of study plans, raw data,
final reports & specimen to prevent untimely
deterioration
Waste Disposal
Appropriate collection,
storage & disposal facilities
and decontamination
procedures

15. 15
GLP
Apparatus, Materials & Reagents
Apparatus, including
validated computerised
systems should be of
appropriate design &
adequate capacity
Chemicals, reagents and
solutions should be
labelled to indicate
identity, Conc, DOE &
storage instructions
Apparatus to be periodically
inspected, cleaned,
maintained, and calibrated
according to Standard
Operating Procedures.
Should not interfere
adversely with the test
systems.

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GLP
Test Systems
Physical/ Chemical –
appropriately designed apparatus
Integrity of test systems to be ensured
Biological –
Proper storage, housing and handling conditions
Isolation of newly received animals / plants for evaluation
and acclimatisation
Information regarding identity at the containers
Records of source, date of arrival and arrival condition
Interference & Contamination free test system

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GLP
Test & Reference Items
Records including item receipt, expiry, quantities and
used in studies.
Handling, sampling & storage procedures should be
identified.
Verification system for sponsor supplied test item.
Stability of test & Reference item under storage and test
conditions.
Stability in case of vehicle to be determined.

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GLP
Standard Operating Procedure
1. Test facility should have a written SOP approved by management
2. SOPs should be available wherever applicable e.g.

Test and reference items
Apparatus, materials and reagents
Record keeping, reporting, storage and retrieval
Test system
Quality assurance procedures
3. Any deviations from SOP should be documented
& acknowledged by SD and PI

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GLP
Performance of The Study
Contents of Study Plan
Identification of the study, the test and reference item
Information - sponsor and the test facility, SD, PI
Test methods – reference to OECD/other test guidelines
Issues – justification of selection
Records
Conduct of the Study
Unique identification for each test item
According to the study plan
Recordings of data should be signed or initialled and dated
For each study, a written plan –
•Approved by SD, management, sponsor
•Verified for GLP compliance by QAU
•If required, national regulation

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GLP
Reporting of study Results
Information
Test Facility, Sponsor
SD, PI, Study
Personnel
Identification
Study
Test & Reference Item
Dates
Starting & completion
dates
Statement
QAP statement with
details of inspections
Results
A summary
Analysis,
Discussions
Description
Materials & methods
Ref. to guidelines
Storage
Location of study
plans, specimens, data
store

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GLP
Storage & Retention of Records
The study plan, raw data, samples of test and reference items, specimens
and the final report of each study.

Records of all inspections by QAP
Records of qualifications, training, experience and job descriptions of
personnel.
Records and reports of the maintenance and calibration of apparatus.
Historical files of all SOP

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GLP
GLP in our country

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GLP
NGCMA
National GLP-compliance Monitoring Authority was established by
the Department of Science & Technology
Approval of the Union Cabinet on April 24, 2002
Full-member for Mutual Acceptance of Data (MAD) in the OECD's
Working Group on GLP from March, 2011
The Authority has certified 31 TF in India as GLP compliant

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GLP
Scope of GLP application to NGCMA (India)
Physical-chemical testing
Toxicity studies
Mutagenicity studies
Environmental toxicity studies on aquatic and terrestrial
organisms
Studies on behaviour in water, soil and air, bio-accumulation
Studies on effects on natural ecosystems
Analytical and chemical testing

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GLP
•GLP-compliance Certification
(valid for a 3 years)
GLP Certification process

26. 26
GLP
GLP Application form & certificate

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GLP
Are we ready for GLP?
when we
do what we
write
when we
write what we
do
We will achieve GLP …

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GLP
•GLP is an FDA regulation which is accepted and
approved as international standards by OECD
to avoid the fraud
activities of the
testing laboratories for
pesticides,
pharmaceuticals, food
additives, dyes
to save the human and
environmental health
also erect good
international trade
and establish good
relationship among
the countries
•GLP compliance is monitored in India by NGCMA
since 2002.
Summary

29. Thank
You