shayana~glp final
TRANSCRIPT
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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