shayana~glp final

8/6/2019 Shayana~GLP Final

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GOOD LABORATORYGOOD LABORATORYPRACTICESPRACTICES

Presented By:Presented By:ShayanaShayana GoraGora

M.PharmM.Pharm QA (QA (IindIind Sem.)Sem.)


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Research

By FDA standards . . .

A VERY uncontrolled,

undisciplined activity!!!

Note: Innovation is the key.


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Development

By comparison . . .

Much more disciplined.

GLP and cGMP become considerations.


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Manufacturing

Must be even more disciplined . . .

cGMP takes priority

QC becomes an important driver!


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What is the intent ofregulations?

Provide assurance of identity, quality, and strength of

pharmaceuticals.

Assure that correct procedures have been followed.

Provide documentation, traceability.

Overall Intent:

To assure Quality is built in to the approach.

The ability to consistently produce the

same product to meet the samespecifications time after time!

Stronger, purer, higher assay, or higher

yield . . . is not better!


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Definition of GLP:

It is a quality system concerned with the organizational processand the conditions under which non-clinical and environmentalsafety studies are planned, performed, monitored, recorded,

archived and reported.


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Why GLP?

Development ofquality test data

Mutual acceptance of data

Avoid duplication of data

Avoid technical barriers to trade

Protection of human health and the environment


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ScopeNon-clinical safety testing of test items

contained in

Pharmaceutical products Pesticide products

Cosmetic products

Veterinary drugs

Food and feed additives

Industrial chemicals


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HistoryHistory

In 1979, GLP regulations became effective under

21 code of federal regulation (CFR) part 58 whichapply to non-clinical safety studies regulated by US FDA.

In 1981, Organization for Economic Co-operation and Development(OECD) adopted FDA regulations.

In 1997, OECD issued the series on principles of GLP and compliancemonitoring.

National GLP Compliance Monitoring Authority was established bythe Department of Science & Technology, Government of India, with theapproval of the Union Cabinet on April 24, 2002.


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ApplicabilityApplicability andand

relationrelation to otherto otherregulationsregulations

Applicability


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Relation to other regulationsRelation to other regulations


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TESTTEST FACILITYFACILITY

ORGANIZATION ANDORGANIZATION ANDPERSONNELPERSONNEL


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Organization andPersonnel

Organization andPersonnel

58.2958.29

((a)Each individual engaged in the conduct of ora)Each individual engaged in the conduct of orresponsible for the supervision of a nonclinicalresponsible for the supervision of a nonclinicallaboratory study shall havelaboratory study shall have educationeducation,, trainingtraining, and, andexperienceexperience, or combination thereof, to enable that, or combination thereof, to enable thatindividual to perform the assigned functions.individual to perform the assigned functions.

(b)Each testing facility shall(b)Each testing facility shall maintainmaintain a currenta currentsummarysummary ofoftrainingtraining and experience and joband experience and jobdescription for each individual engaged in ordescription for each individual engaged in orsupervising the conduct of a nonclinical laboratorysupervising the conduct of a nonclinical laboratorystudy.study.

Three Key Responsibilities:Three Key Responsibilities:

Testing Facility ManagementTesting Facility Management

Study DirectorStudy Director

Quality Assurance UnitQuality Assurance Unit


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58.33 StudyDirector58.33 StudyDirector

For each nonclinical laboratory study, aFor each nonclinical laboratory study, a scientistscientist oror

otherother professionalprofessional of appropriate education, training,of appropriate education, training,and experience, or combination thereof, shall beand experience, or combination thereof, shall be

identified as theidentified as the studystudy directordirector. The study director has. The study director has

overalloverall responsibilityresponsibility for the technical conduct of thefor the technical conduct of the

study, as well as for the interpretation, analysis,study, as well as for the interpretation, analysis,

documentation, and reporting of results, anddocumentation, and reporting of results, and

represents therepresents the singlesingle pointpoint ofof studystudy controlcontrol..


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58.35Quality Assurance

58.35Quality AssuranceUnitUnit

A testing facility shall have aA testing facility shall have a qualityquality assuranceassurance unitunit whichwhich

shall be responsible forshall be responsible for monitoringmonitoring each study to assureeach study to assure

management that the facilities, equipment, personnel,management that the facilities, equipment, personnel,

methods, practices, records, and controls are inmethods, practices, records, and controls are in

conformanceconformance withwith thethe regulationsregulations in this part. For anyin this part. For any

given study, the quality assurance unit shall be entirelygiven study, the quality assurance unit shall be entirely

separate from and independent of the personnel engagedseparate from and independent of the personnel engagedin the direction and conduct of that study.in the direction and conduct of that study.


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FacilitiesFacilities58.41 General58.41 General

Each testing facility shall be of suitable size and constructionEach testing facility shall be of suitable size and constructionto facilitate the proper conduct of nonclinical laboratoryto facilitate the proper conduct of nonclinical laboratory

studies. It shall be designed so that there is a degree ofstudies. It shall be designed so that there is a degree of

separation that will prevent any function or activity fromseparation that will prevent any function or activity fromhaving an adverse effect on the study.having an adverse effect on the study.

Animal care facilitiesAnimal care facilities

Animal supply facilitiesAnimal supply facilities

Facilities for handling test and control articlesFacilities for handling test and control articles

Laboratory operation areasLaboratory operation areas

Specimen and data storage facilitiesSpecimen and data storage facilities


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EquipmentEquipment

58.61 Equipment Design58.61 Equipment Design

58.63

Maintenance and Calibration

58.63

Maintenance and Calibration

(b) The written standard operating procedures ...(b) The written standard operating procedures ...

(c) Written records shall be maintained ...(c) Written records shall be maintained ...

Appropriately designed

Adequate thru-put capacity

Appropriately located

Routinely maintained & calibrated


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58.81 StandardOperating58.81 StandardOperatingProceduresProcedures

(a) A testing facility shall have standard operating procedures(a) A testing facility shall have standard operating procedures inin

writingwriting setting forth nonclinical laboratory study methods ... tosetting forth nonclinical laboratory study methods ... toinsure the quality and integrity of the data generated ...insure the quality and integrity of the data generated ...

Animal room preparation

Animal care

Receipt, ID, storage, handling, mixing & sampling of test & controlarticles

Test system observations


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Lab tests

Handling of moribund or dead animals

Necropsy or postmortem exams of animals

Collection & ID of specimens

Histopathology

Data handling, storage & retrieval

Equipment maintenance & calibration

Transfer, proper placement & ID of animals

Department : Q.C.

SOP NO.:

GLP/ 003

Page No. 1 of 2

Title : Cleaning Laboratory Glassware

Effective Date :

01/04/2000

Supersedes:

New

To be

Reviewed:01/04/2001

Prepared By : Checked By

:

Authorised By :


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58.90 Animal Care58.90 Animal Care

(e) Animals of different species shall be housed in separate(e) Animals of different species shall be housed in separate

rooms when necessary. Animals of the same species, butrooms when necessary. Animals of the same species, butused in different studies, should not ordinarily be housed inused in different studies, should not ordinarily be housed in

the same room when inadvertent exposure to control orthe same room when inadvertent exposure to control ortest articles or animal mixtest articles or animal mix--up could affect the outcome ofup could affect the outcome of

either study. If such mixed housing is necessary,either study. If such mixed housing is necessary, adequateadequatedifferentiationdifferentiation by space andby space and identificationidentification shall be made.shall be made.


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Adequate labeling

Identity

Concentration

Storage requirements

Expiration date

Reagents & Solutions


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Test and Control Articles

58.105 Test and Control Article Characterization58.105 Test and Control Article Characterization

(a) The identity, strength, purity, and composition(a) The identity, strength, purity, and compositionwhich appropriately define the test or controlwhich appropriately define the test or control

article shall be determined for each batch andarticle shall be determined for each batch and

shall be documented.shall be documented.

(b) The stability of each test or control article shall(b) The stability of each test or control article shall

be determined ...be determined ...

Adequate characterization

Proper receipt, storage, distribution

When mixed with a carrier, adequate

methods to confirm Mixture uniformity

Article concentration

Article stability


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Protocol for Conductof a Nonclinical

Laboratory Study

58.120 Protocol58.120 Protocol

(a) Each study shall have an approved written protocol(a) Each study shall have an approved written protocol

that clearly indicates the objectives and all methods forthat clearly indicates the objectives and all methods for

the conduct of the study.the conduct of the study.

58.130 Conduct of a Non58.130 Conduct of a Non--clinical Laboratory Studyclinical Laboratory Study

(a) The nonclinical laboratory study shall be conducted in(a) The nonclinical laboratory study shall be conducted in

accordance with the protocolaccordance with the protocol


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Study Implementation Written, approved protocol indicating test objectives &

methods

Study conducted in accordance with protocol

Study monitoring to confirm protocol compliance

Appropriate labeling of specimens by test system,

study, nature & collection date

Records of gross findings from postmortems available

to pathologist for specimen histopathology


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Standard data capture/recording requirements

Legibility

Permanence

Accountability

Changes


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58.185 Reporting of Non58.185 Reporting of Non--clinical Laboratory Studyclinical Laboratory Study

ResultsResults

(a) A final report shall be prepared for each(a) A final report shall be prepared for eachnonclinical laboratory study ...nonclinical laboratory study ...

58.190 Storage and Retrieval of Records and Data58.190 Storage and Retrieval of Records and Data

(a) All raw data, documentation, protocols, final(a) All raw data, documentation, protocols, final

reports, and specimens ... shall be retained.reports, and specimens ... shall be retained.

Records & Reports


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Records & Reports Final report of results

Study records & data methodically archived tofacilitate expedient retrieval

Study documents

Raw data

Specimens

Protocols

QA inspections

Personnel training & qualifications

Calibration & maintenance records


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Records retention (shortest of):

2 yr afterFDA marketing clearance

5 yr after data submitted to FDA in support of

marketing application

2 yr after Sponsor decision not to proceed with

marketing application

Wet specimens hold as long as viable

Records transferable with written FDA notification


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FacilityDisqualification

Grounds for disqualification:

Failure to comply with regulations &

Noncompliance adversely affects study validity &

Previous regulatory actions have been

unsuccessful in modifying facility operations


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Storage and Retention of Records

and Materials

Retention period to be defined

If any study material is disposed of before expiry the

reason to bejustified and documented Index of materials retained in the archives

Controlled access to the archives

In case that the laboratory goes out of business the

archives are transferred to the relevant sponsors(s)


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Summary

GLP v/v ISO 9000 and ISO 17025

Non-clinical health and environmental safety studies

Physical and chemical test systems

biological test systems

GLP is required on large scale basis

To segregation of various complex procedures

For prominent restoration of data

Improving the efficiency of testing facility.

It is a study based process.


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21 CFR 58 Good Laboratory Practice forNon-clinical

Laboratory Studies

Div. of Scientific Investigations: Good Laboratory Practice

www.fda.gov/cder/Offices/DSI/goodLabPractice.htm

BIMO Compliance Program Guidance 7348.808A: GLP Program

www.fda.gov/ora/compliance_ref/bimo/7348_808A/Default.htm

Where to Get MoreInformation


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Commission Directive 1999/11/EC

Commission Directive 1999/12/EC

http://europa.eu.int/comm/enterprise/chemicals/glp/legisl/dir/brsum/9911.htm

http://www.doh.gov.uk/practice.htm

http://www.oecd.org under environment/chemicalsafety

www.glp.admin.ch


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ThankYou

shayana~glp final

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