2. GLP: GOOD LABORATORY
PRACTICE
• GLP is an FDAregulation.
• GLP is a formal regulation that wascreated
by the FDA (United states food and drug
administration) in 1978.
3. Definition of GLP
• GLP embodies a set of principlesthat
provides a frame work within which
laboratory studies are planned
performed, monitored, and archived
and reported.
4. WHY WAS GLP CREATED?
• In the early 70’s FDA became
awareof casesof poor
laboratory practice all overthe
United States.
• They discovered a lot
fraudulent activities and alot
of poor labpractices.
• Examplesof some of these
poor lab practices foundwere
1. Equipment not been
calibrated to standard form ,
therefore giving wrong
measurements.
2. Incorrect/inaccurate accounts
of the actual labstudy.
3. Inadequate testsystems.
5. Purpose of GLPs:
• GLP is tocertify thateverystepof the
analysis is valid orNot.
• Assure the quality & integrity ofdata
submitted to FDA in support of the
safety of regulated products.
• GLPs have heavy emphasis on data
recording, record & specimenretention.
6. GOOD LABORATORY
PRACTICES PRINCIPLES.
1. Test Facility Organisation and Personnel.
2. Quality AssuranceProgramme(QAP).
3. Facilities.
4. Apparatus, Material and Reagents.
5. Test systems.
6. Testand Reference Substances.
7. Standard Operating Procedures(SOP).
8. Performance of The Study.
9. Reporting of Study Results.
10. Storageand Retention of Recordsand materials.
7. 1.Test Facility Organizationand
Personnel
Study Personnel Responsibilities
• Should have the Knowledge of theGLP
principles.
• Access to thestudyplanand appropriate
SOP’s.
• Comply with the instructions of theSOP’s.
• Record rawdata.
• Study personnel are responsible forthequality
of theirdata.
• Exercise health precautions to minimizerisk.
• Ensure the integrity of thestudy.
8. 2.Quality Assurance Program
Responsibilities of the QAPersonnel
• Access to the updated study plans and SOP’s.
• Documented verification of the compliance of study
plan to the GLP principles.
• Inspections todeterminecomplianceof thestudywith
GLP principles.
• Three types of inspection.
– Study-based inspections.
– Facility-based inspections.
– Process-based inspections.
• Inspection of the final reportsforaccurate and full
description.
• Reportthe inspection resultsto the management.
• Statements.
9. 3. Facilities
• Suitable size, construction andlocation.
• Adequate degree of separation ofthe
different activities.
• Isolation of test systems andindividual
projects to protect from biological
hazards.
• Suitable rooms for the diagnosis,
treatment and control of diseases.
• Storage rooms.
10. 4. Apparatus, Materialsand
Reagents
• Apparatus of appropriate designand
adequatecapacity.
• Documented Inspection, cleaning,
maintenance and calibration ofapparatus.
• Apparatus and materials not tointerfere
with the testsystems.
• Chemicals, reagent and solutions should be
labeled to indicate identity, expiry and
specific storageinstructions.
11. 5. Test Systems
• Physical and chemical testsystems.
• Biological test systems.
• Records of source, date of arrival,
and arrival conditionsof test systems.
• Proper identificationof test systems in
their container or whenremoved.
• Cleaning and sanitization of containers.
• Pest control agents to bedocumented.
12. 6. Test and ReferenceItems
• Receipt, handling, sampling and storage
• Characterization.
• Known stability of test andreference
items.
• Stability of the test item in itsvehicle
(container).
• Experiments to determine stabilityin
tank mixers used in the fieldstudies.
• Samples for analytical purposesfor
each batch.
13. 7.Standard Operating
Procedures (SOP)
Written procedures for a laboratories
program.
They define how to carry outprotocol-
specified activities.
Most often written in achronological
listing of actionsteps.
They are written to explain howthe
procedures aresuppose towork.
14. 7.SOP’s
Routine inspection, cleaning,
maintenance, testing and calibration.
Actions to be taken in responseto
equipment failure.
Keeping records, reporting, storage,
mixing, and retrieval of data.
Definition of rawdata.
Analytical methods.
15. 8. Performance of the Study
• Prepare the Studyplan.
• Content of the studyplan.
› Identification of thestudy.
› Records.
› Dates.
› Reference to test methods.
› Information concerning thesponsor
and facility.
• Conduct of thestudy.
16. 9. Reporting of Study Results
• Information on sponsorand test facility.
• Experimental starting andcompletion
dates.
• A Quality Assurance ProgramStatement.
• Description of materials and testmethods.
• Results.
• Storage (samples, reference items, raw
data, final reports)etc.
17. 10. Storage and Retentionof
Records and Materials
– The study plan, raw data,samples.
– Inspection data and master
schedules.
– SOPs.
– Maintenance and calibrationdata.
– If any study material is disposedof
before expiry the reason to be
justified and documented.
– Index of materials retained.
18. Do this forGLP
• Keep the thingsat its location afteruse.
• Store heavy thingsat bottom & if possibleon
Trollies.
• Give nameof location toeverything.
• Follow “Everything has the place & Everythingat
its place” principle.
• Prepare location list & displayit.
• Put ladders for things stored ontop.
• Identify everything with its name/purpose.
• Follow “FIFO” to prevent old accumulationfor
laboratorychemicals.
19. Benefits of good laboratory
practices.
• It will give better image of company asa
Qualityproducer in Global market.
• Provide hot tips on analysis of data as
well as measure uncertainty andperfect
record keeping.
• Provide guideline for doing testingand
measurement indetail.
• Provideguidelines and bettercontrol
for maintenance of instruments,
environment control, preservation of
test recordsetc
