This presentation provides knowledge about GLP ,Advantages, Disadvantages, Principles of GLP

1. GOODLABORATORYPRACTICE
Presented by,
K.Meghana M.Pharm 1st Year
Department of Pharmacology
K.K College of Pharmacy, Chennai.

2. What is good laboratory practice ?
•It is a formal regulation proposed by
USFDA on Nov 19, 1976.
•It is a quality system concerned with
the organizational process and the
conditions under which non –clinical
health & environmental safety studied
are planned, performed, monitored,
achieved and reported.

3. Drug
companies
Government and
company
Laboratories
Hazard
Assessment
International trade
GLP
Data

4. Advantages

5. • Assures the data are the true
reflection of results obtained from
the study.
• Preclinical Safety and Residue
Safety.
• Mutual acceptance of data.
• Increases public confidence.
• Shortens the time to market for
new products.

6. Disadvantages

7. • More man power is required.
• Expensive process.
• Time consuming process.

8. Objectives

9. • To assure that the data are the
true reflection of results obtained
from the study.
• To make sure that the data is
traceable.
• To promote international
acceptance of tests.

10. GLP Principles
Quality
Assurance
Program
Storage and
retention of
records &
materials
Apparatus,
Materials,
Reagents
Test
Systems
Test and
Reference
Substance
s
Standard
operating
procedures
Performace
of studyFacilities
Reporting of
study results
Testing
facility
organisation
& personnel

11. 1.Test Facility Organization and Personnel
A. Test Facility Management’s Responsibilities:
• Sufficient number of qualified
personals, Appropriate facilities,
equipment and materials are available
for the timely and proper conduct of the
study.
• Ensure the record maintenance of
qualification, training and experience.
• Job description for each professional
and technical individual.
• Documented approval of study plan by
the study director.

12. B. Study Director’s Responsibilities:
• Any amendments to the study plan by
dated signature.
• Availability of SOPS to the personnel.
• Raw data generated are fully
documented and recorded.
• Sign and date the final report.
• Ensure after completion of the study,
the study plan, the final report, raw
data and supporting material are
archived.

13. C. Principal Investigator’s Responsibilities:
• Principal Investigator will ensure that
the delegated phases of the study are
conducted in accordance with the
applicable principles of GLP.

14. 2.Quality Assurance Programme:
• Quality Assurance Personnel.
• Study plan contains the information
verification.
• Conduct Inspections
Study based inspections
Facility based inspections
Process based inspections
• Records of such inspections should be
retained.

15. 3. Facilities
1. General Facilities
A. Testing System Facilities:
• Suitable size, construction and location.
• Adequate degree of separation of
different activities.
• Laboratories should be well ventilated,
free for dusts, drafts and extreme
temperatures.
• Minimum 150 Square feet of floor space
and minimum 6 linear feet of usable
bench space should be provided for
each analyst.

16. B. Archive Facilities:
• Secure storage and retrieval of study
plans, raw data, final report and
specimens to prevent untimely
detoriation.
C. Waste Disposal:
• Appropriate collection, storage and
disposal facilities and decontamination
procedures.

17. 2. Animal Care Facilities:
• Located away from testing laboratories
preferably in a separate building.
• Contamination risk is reduced by barrier
system.
• Separate areas for animals of different
species and studies.
• Separate area for diagnosis, treatment and
control of laboratory animal diseases.
• Lightning should be proper.
• Maintain room temperature, humidity and
air changes in animal quarters.

18. 4.Apparatus, Materials & Reagents:
• Apparatus including validated computerized
systems used for the generation, storage &
retrieval of data & for controlling
environmental factors relevant to the study.
• Apparatus used in a study should be
periodically inspected, cleaned, maintained &
calibrated according to SOP.
• Apparatus & materials used in a study should
not interfere adversrly with the test systems.
• Chemicals, solutions and reagents should be
labeled to indicate identity, expiry date &
specific storage instructions. The expiry date
may be extended on the basis of documented
evaluation or analysis.

19. 5.Test Systems:
• Physical and chemical test systems.
• Biological test systems.
• Record of source, date of arrival &
arrival condition of the test systems.
• Proper identification of the test
systems in their container or when
removed.
• Cleaning and stabilization of
containers.
• Pest control agents to be documented.

20. 6.Test and Reference items:
• Receipt, handling, sampling & storage.
• Characterization.
• Known stability of test and reference
items.
• Samples for analytical purposes for
each batch.

21. 7.Standard Operating Procedures
(SOPS):
• Written documents specifying
procedures for laboratories program.
• Testing facility should have a written
SOP approved by management.
• Routine inspection, cleaning,
maintenance, testing & calibration.
• Actions to be taken in response to
routine failure.

22. 8.Performance of the study:
• Study plan.
• Content of the study plan.
• Dates.
• Test Methods.
• Issues(where applicable).
• Records.
• A list of records to be retained.
• Conduct of the study.

23. 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.
• Results.
• Storage.
• Description of materials and test
methods.

24. 10.Storage & Retention of Records &
Materials:
• The study plan, raw data, samples of tests
& reference items, specimens & final
report of each study.
• Records of all inspections performed by
the Quality Assurance Program.
• Records & qualifications, training,
experience & job description of personals.
• Record and reports of the maintenance &
calibration of apparatus.
• Validation documentation for computerized
systems.

25. Any questions?