GLP (Good Laboratories Practice)

GLP is an FDA regulation.
It is defined in OECD principles as ―a quality system concerned with organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
GLP extends to include food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

GLP is a formal regulation that was created by the USFDA in 1978 having worldwide impact.
Non-US companies that wanted to do business with the United states or register their pharmacies in the United States had to comply with the United States GLP regulations.
In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard.

Quality and Integrity of the Safety Data
In the early 70’s FDA became aware of cases of ( PLP ) poor laboratory practice all over the United States.
FDA decided to do an in-depth investigation in 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices.
Examples of some of these ( PLP )poor lab practices found were: Equipment not been calibrated to standard form , therefore giving wrong measurements. Incorrect/inaccurate accounts of the actual lab study.

1. DISCOVER . LEARN. EMPOWERGLP
UNIVERSITY INSTITUTE OF PHARMA
SCIENCES
Pharm.D
GLP (Good Laboratories Practice)
(21PST-324)

2. INTRODUCTION
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GLPisanFDAregulation.
ItisdefinedinOECDprinciplesas―aqualitysystem
concernedwithorganizationalprocessandtheconditionsunder
whichnon-clinicalhealthandenvironmentalsafetystudiesare
planned,performed,monitored,recorded,archivedandreported.
GLPextendstoincludefoodandcoloradditives,animalfood
additives,humanandanimaldrugs,medicaldevicesforhuman
use,biologicalproducts,andelectronicproducts.

3. HISTORY
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GLPisaformalregulationthatwascreatedbytheUSFDAin1978having
worldwideimpact.
Non-UScompaniesthatwantedtodobusinesswiththeUnitedstatesor
registertheirpharmaciesintheUnitedStateshadtocomplywiththeUnited
StatesGLPregulations.
In1981anorganizationnamedOECD(organizationforeconomicco-
operationanddevelopment)producedGLPprinciplesthatareinternational
standard.

4. NEED FOR GLP
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QualityandIntegrityoftheSafetyData
Intheearly70’sFDAbecameawareofcasesof(PLP)poorlaboratory
practiceallovertheUnitedStates.
FDAdecidedtodoanin-depthinvestigationin40toxicologylabs.They
discoveredalotfraudulentactivitiesandalotofpoorlabpractices.
Examplesofsomeofthese(PLP)poorlabpracticesfoundwere:Equipment
notbeencalibratedtostandardform,thereforegivingwrongmeasurements.
Incorrect/inaccurateaccountsoftheactuallabstudy.

5. PRINCIPLES OF
GLP
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To promote the development of quality test data.
Set standards for ensuring the quality, reliability & integrity of studies.
To ensure good operational management
Focus on aspects of study execution i.e. planning, monitoring, recording, reporting,
archiving
Note: Non-clinical laboratory study means in vivo/in vitro experiments in which test
articles are studied prospectively in test systems to determine their safety. Do not
include –studies utilizing human subjects/animal trails.

6. OBJECTIVES
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Characterization of toxic effects with respect to target organs.
Dose dependence
To estimate an initial safe starting dose & dose range for human trials
To identify parameters for clinical monitoring to characterize potential adverse effects
that might occur during clinical trial

7. USFDA
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FOOD AND DRUGS
CHAPTER 1—FOOD AND DRUG ADMINISTRATION DEPARTMENT OF
HEALTH AND HUMAN SERVICES
SUB CHAPTER A–GENERAL 21
CFR PART 58: GOOD LABORATORY PRACTICES (GLP) FOR NON -
CLINICALLABORATORY STUDIES

8. US-FDA
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Subpart A: General Provisions
Subpart B: Organization and Personnel
Subpart C: Facilities
Subpart D: Equipment
Subpart E: Testing Facilities Operation
Subpart F: Test and Control Articles
Subpart G: Protocol for and Conduct of a Non-Clinical Laboratory Study
Subpart J: Records and Reports
Subpart K: Disqualification of Testing Facilities

9. Subpart A: General
Provisions
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This part includes good laboratory practices for conducting non-clinical laboratory
studies that support/intended to support applications for research or marketing permits
for products regulated by FDA including food and colour additives, animal food
additives, human and animal drugs, medical devices for human use, biological
products and electronic products.
Compliance with this part is intended to assure the quality and integrity of the safety
data filed under sections of Food, Drug and Cosmetics Act

10. Subpart B: Organization and
Personnel
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•SECTION 58.29 PERSONAL
Every individual in testing facility Should have education, training, expirence.
Maintain current summary of job ,
Shall be sufficient in number,
Shall take neccesary personal sanitation, health precautions to avoid
contamination of test systems.
Shall clearly understand the functions they are to perform.

11. Subpart C-FACILITIES
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58.41 General―
Each testing facility shall be of suitable size and construction to facilitate the proper
conduct of nonclinical laboratory studies.
It shall be designed so that there is a degree of separation that will prevent any
function or activity from having an adverse effect on the study.
Animal care facilities
Animal supply facilities
Facilities for handling test and control articles
Laboratory operation areas
Specimen and data storage facilities

12. Subpart D-
EQUIPMENT
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58.61 Equipment Design―Equipment used shall be of appropriate design and
adequate capacity
58.63 Maintenance and Calibration
(a)―The written standard operating procedures
(b)―Written records shall be maintained
Log book
Not for GLP use

13. Verification, Calibration AND Standardization OF
EQUIPMENT
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Verification (Testing):external check of equipment accuracy (e.g. check
balance accuracy against weights at laboratory-no adjustment).
Calibration: equipment is adjusted based on comparison to certified or known
reference materials (e.g. balance adjusted after comparison to certified
weights by trained professional).
Standardization: comparison with similar equipment (e.g. use two
thermometers of similar design to compare readings.

14. Subpart E-FACILITIES TESTING
OPERATION
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STANDARD OPERATINGPROCEDURES:
(a)A testing facility shall have standard operating procedures in writing setting
forth study methods that management is satisfied are adequate to insure the
quality and integrity of the data generated in the course of a study.
(b)Written procedures for a laboratories program: They define how to carry out
protocol-specified activities.
(c)Most often written in a chronological listing of action steps.
(d)They are written to explain how the procedures are suppose to work.

15. ANIMAL CARE
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There should be SOP’s for housing, feeding, handling and caring of animals.
Diagnosis, authorizations of treatment of treatment, description of treatment, each
date of treatment shall be documented & retained.
REAGENTS and SOLUTIONS:
Reagents and solutions in laboratory areas shall be labelled to indicate identity, titer
or concentrations, storage requirements and expiration date.

16. Subpart F: Test and Control
Articles
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Test and control article characterisation:
the identity , strength, purity and composition or other characteristics which will
define the test or control articles shall be determined for each batch & documented.
Method of synthesis, fabrication, derivation of the articles shall be documented by
sponsor /testing facility.
Procedures shall be established for proper handling.
Distribution is made in a designed manner to preventpossibility of contamination,
deterioration and damage.

17. SUBPART G-PROTOCOL FOR
CONDUCT OF A NON-CLINICAL
LABORATORY STUDY
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58.120 Protocol―Each study shall have an approved written protocol that clearly
indicates the objectives and all methods for the conduct of the study.
58.130 Conduct of a Non-clinical Laboratory Study―The nonclinical laboratory study
shall be conducted in accordance with the protocol.

18. Subpart J: Records
and Reports
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58.185 Reporting of Non-clinical Laboratory Study Results―A final report shall be
prepared for each nonclinical laboratory study Which include a detailed
documentation of how whole study carried out by the testing facility
58.190 Storage and Retrieval of Records and Data―All raw data, documentation,
protocols, final reports, and specimens Generated as a result of the study shall be
retained and shall be orderly stored in archives.

19. Subpart K: Disqualification of Testing
Facilities
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Grounds of dis-qualification: The commissioner may disqualify a testing facility upon
finding:
A) The testing facility failed to comply with one or more of the regulations.
B) Non-compliance adversely affected the validity of the non-clinical laboratory study.

20. CONCLUSION
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These Regulations specify minimum standards for the conduct of safety testing to
achieve great results with minimal adverse effects.
The Principles may be considered as a set of criteria to be satisfied as a basis for
ensuring the quality, reliability and integrity of studies, the reporting of verifiable
conclusions and the traceability of data.

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26. REFERENCES
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•http://www.fda.gov/oc/gcp/guidance.htmhttp://www.clinicaltrials.gov/
http://www.fda.gov/oc/ohrt/irbs/websites.htmlhttp://ohrp.osophs.dhhs.gov/
http://privacyruleandresearch.nih.gov/http://en.wikipedia.org/wiki/ICH-GCP
Handbook: good laboratory practice (GLP): quality practices forregulated non-
clinical research and development -2nd ed., WHOLibrary Cataloguing-in-
Publication Data, 2nd ed., 7,15-20OECDPrinciples of Good Laboratory
Practice (as revised in 1997)".OECD Environmental Health and Safety
Publications (OECD)
1.1998.http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1
_1_1_37465,00.html.Schneider, K (1983(Spring)). "Faking it: The case
againstIndustrial Bio-Test Laboratories". Amicus Journal (NaturalResources
Defence Council): 14-26.

27. THANK YOU
For queries
Email: [email protected]
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