the principle and protocol of good laboratory practices

1. GOOD
LABORATORY
PRACTICES
PRESENTED BY
ANU K THANKACHAN
1ST M. PHARM PHARMACEUTICAL ANALYSIS
ST JAMES COLLEGE OF PHARMACEUTICAL SCIENCES

2. GLP: GOOD LABORATORY PRACTICE
 GLP is an FDA regulation.
 GLP is a formal regulation that was created by the FDA (United states food
and drug administration) in 1978.
2

3. What is 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.
3

4. WHY WAS GLP CREATED? 4
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.

5. Purpose of GLPs: 5
• GLP is to certify that every step of the
analysis is valid or Not.
• Assure the quality & integrity of data
submitted to FDA in support of the safety
of regulated products.
• GLPs have heavy emphasis on data
recording, record & specimen retention.

6. Scope of GLP
 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
6

7. Objectives of GLP
7
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
internation
al
acceptance
of tests

8. 8
Protocols of GLP

9. 9Organisation & 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

10. 10
Organisation & Personnel – Study Director’s responsib
 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.

11. 11Organisation & 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

12. 12Quality 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

13. 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
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14. Cont …….
Archive facilities
 Secure storage and retrieval of study plans, raw data, final
reports & specimen to prevent deterioration
Waste Disposal
Appropriate collection, storage & disposal facilities and
decontamination procedures
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15. 15
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, 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.

16. 5. Test Systems
16
 Physical/ Chemical
 Biological

17. 6. Test and Reference Items 17
• Receipt, handling, sampling and storage
• Characterization.
• Known stability of test and reference items.
• Stability of the test item in its vehicle
(container).
• Samples for analytical purposes for each
batch

18. 7.Standard Operating Procedures (SOP) 18
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

19. 19Performance ofThe Study
For each study, a written plan –
• Approved by SD, management, sponsor
• Verified for GLP compliance by QAU
• If required, national regulation
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

20. 20Reporting of study Results
Informatio
n
Identification
Dates
Statemen
t
Result
Descriptio
n
Materials
Location of study
plans, specimens,
data store

21. 21Storage & 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

22. 22
GLP in our country

23.  National GLP-compliance Monitoring Authority was
established by the Department of Science &Technology
 Approval of the Union Cabinet on April 24, 2002
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24. 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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25. 25
Application
• The test facilities/
laboratories have to apply in
the prescribed application
form
Inspection
• A pre-inspection of the laboratory is
carried out by the GLP inspectors,
followed by a final inspection.
Report
Submission
• The report, prepared by the
inspection team, is put to the
Technical Committee for
recommendation to
Chairman, NGCMA
•
GgggggCertification
•GLP-compliance
Certification
(valid for a 3 years)
GLP Certification process

26. 26GLP Application form & certificate

27. Are we ready for GLP?
27
when we
do what we write
when we
write what we do
We will achieve GLP …

28. REFERENCE
 NARENDRA PRADAP SING SENGER. PHARMACEUTICAL ANALYSIS III. P
48 - 52
 SANDY WEINBERG. GOOD LABORATORY PRACTICES
REGULATION. 4th ed . p 131 - 150
 http/Wikipedia.org/ GLP
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 G.E. Paget, Good Laboratory Practice MTP Press
Limited, Lancaster 1979. p 56 - 65

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