Good Laboratory Practice

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Text of Good Laboratory Practice

  • Dr. Kaushik Mukhopadhyay Pharmacology, Final year PGT IPGME&R

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    Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

    (OECD, 1997)What is GLP?Adamo JE et al. A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure. Acad Med. 2012 Mar;87(3):27984.

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    Historical Background

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    GLP TIMELINEGLP was first introduced in New ZealandEarly 1970sIndustrial Bio Test Lab case was most notableFDA became aware of cases of poor laboratory practice all over the US decided to do an in-depth Investigation on 40 toxicology labs.

    197821 CFR, Part 58FDA promulgated the Good Laboratory Practice (GLP) Regulations

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    National GLP-compliance Monitoring Authoritywas established by the Department of Science & Technology1981An organization named OECD produced GLP principles that are international standardInternational Standard20022011India becomes full-member for Mutual Acceptance of Data (MAD) in the OECD's Working Group on GLP

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    Objectives of GLPTrue reflectionEnsure HonestyInternational acceptanceGLP makes sure that the data submitted are a true reflection of the results that are obtained during the study.GLP also makes sure that not to indulge in any fraud activity by labsPromotes international acceptance of tests

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    Scope of GLP (OECD)Principles of GLP apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing -

    Pharmaceuticals Pesticides Food and feed additives Cosmetic productsVeterinary drug products and similar productsIndustrial chemicals

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    GLP Principles

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    GLP Principles0102030408070605Test Facility Organisation and Personnel

    Quality Assurance ProgrammeFacilitiesApparatus, Material & ReagentsReporting of Study Results

    Performance of the Study

    Test and Reference Items & SOPTest Systems09Storage and Retention of Records and Materials

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    Organisation & Personnel Managements Responsibilities

    Ensure sufficient number of qualified personnel, appropriate facilities, equipment, and materials Ensure the maintenance of a record of the qualifications, training, experience.

    Proper training of personnel to assigned functions

    Job description for each professional and technical individual. To establish and follow SOP Quality assurance program with designated personnel

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    Organisation & Personnel Study Directors responsibilities

    Approval of protocols & the study plan including amendments Ensure QA personnel and study personnel are updated with study plans & SOP Ensure the follow up of SOPs periodically and take appropriate corrective action Archiving Raw data, supporting materials and final report.

    The individual responsible for the overall conduct of the non-clinical health and environmental safety study

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    Organisation & Personnel

    Ensures the study is conducted in accordance with GLP

    Recording of all raw data in compliance with the principles of GLP

    Deviations from the instructions to be reported the PI or SD

    Takes health precautions and personal safety

    Study Personnels ResponsibilitiesPrincipal Investigators Responsibilities

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    Quality Assurance ProgrammeMaintains copies of protocols & SOPs

    Inspects each laboratories and man at work Study-based inspectionsFacility-based inspectionsProcess- based inspections Determines any deviation from approved protocol and report to SD, PI & management Prepare a statements to be included in final report containing dates & types of inspectionAn individual or a group designatedby management to assure studies are in compliance with GLP Principles

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    FacilitiesTest System FacilitiesSufficient amount of rooms and areas to assure isolation of test systemsAdequately protected storage area separate from test systemsAreas available for the diagnosis, treatment and control of diseasesArchive facilitiesSecure storage and retrieval of study plans, raw data, final reports & specimen to prevent untimely deteriorationWaste DisposalAppropriate collection, storage & disposal facilities and decontamination procedures

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    Apparatus, Materials & ReagentsApparatus, including validated computerised systems should be of appropriate design & adequate capacityChemicals, reagents and solutions should be labelled to indicate identity, Conc, DOE & storage instructionsApparatus to be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures.Should not interfere adversely with the test systems.

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    Test Systems

    Physical/ Chemical appropriately designed apparatus Integrity of test systems to be ensured Biological Proper storage, housing and handling conditionsIsolation of newly received animals / plants for evaluation and acclimatisationInformation regarding identity at the containersRecords of source, date of arrival and arrival conditionInterference & Contamination free test system

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    Test & Reference ItemsRecords including item receipt, expiry, quantities and used in studies. Handling, sampling & storage procedures should be identified.

    Verification system for sponsor supplied test item.

    Stability of test & Reference item under storage and test conditions.

    Stability in case of vehicle to be determined.

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    Standard Operating Procedure1. Test facility should have a written SOP approved by management

    2. SOPs should be available wherever applicable e.g. Test and reference itemsApparatus, materials and reagentsRecord keeping, reporting, storage and retrievalTest system Quality assurance procedures

    3. Any deviations from SOP should be documented & acknowledged by SD and PI

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    Performance of The StudyContents of Study Plan Identification of the study, the test and reference item Information - sponsor and the test facility, SD, PITest methods reference to OECD/other test guidelinesIssues justification of selection Records

    Conduct of the Study Unique identification for each test itemAccording to the study planRecordings of data should be signed or initialled and datedFor each study, a written plan Approved by SD, management, sponsorVerified for GLP compliance by QAUIf required, national regulation

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    Reporting of study ResultsInformation Test Facility, SponsorSD, PI, Study PersonnelIdentification StudyTest & Reference Item DatesStarting & completion datesStatementQAP statement with details of inspectionsResultsA summaryAnalysis, DiscussionsDescriptionMaterials & methodsRef. to guidelinesStorageLocation of study plans, specimens, data store

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    Storage & Retention of Records

    The study plan, raw data, samples of test and reference items, specimens and the final report of each study. Records of all inspections by QAP

    Records of qualifications, training, experience and job descriptions of personnel. Records and reports of the maintenance and calibration of apparatus. Historical files of all SOP

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    GLP in our country

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    NGCMA National GLP-compliance Monitoring Authoritywas established by the Department of Science & Technology Approval of the Union Cabinet on April 24, 2002 Full-member for Mutual Acceptance of Data (MAD) in the OECD's Working Group on GLP from March, 2011 The Authority has certified 31 TF in India as GLP compliant

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    Scope of GLP application to NGCMA (India)Physical-chemical testingToxicity studiesMutagenicity studiesEnvironmental toxicity studies on aquatic and terrestrial organismsStudies on behaviour in water, soil and air, bio-accumulationStudies on effects on natural ecosystemsAnalytical and chemical testing

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    GLP Certification process

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    GLP Application form & certificate

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    Are we ready for GLP?when we do what we writewhen we write what we doWe will achieve GLP

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    GLP is an FDA regulation which is accepted and approved as international standards by OECD

    GLP compliance is monitored in India by NGCMA since 2002. Summary

  • Thank You

    Not GLP Excellence of a laboratoryQuality of an organisationQuality of a productProfessional competence

    PLANNED..which is why great emphasis is placed on the study plan (protocol) and to planned changes throughout the study.PERFORMED.this refers to the standard operat-ing procedures (SOPs) which are a GLP require-ment.RECORDEDi.e. the collection of raw data and the recording of deviations, if any, during the study.REPORTED.one of the problems pre-GLP was that study reports did not always reect the study data accurately. Assuring accuracy in the report has now become an essential part of GLP.ARCHIVED.as studies may be audited many years after their completion, it is important that the study data, specimens, samples and reports are properly archived. MONITORED..monitoring by study staff, quality assurance personnel and national inspectors helps to assure GLP compliance.

    *Poorly-trained Study Directors and study personnelPoorly-designed protocolsRaw data badly collected - not correctly identified, without traceability - not verified or approved by responsible personsPoor animal husbandryEquipment not properly calibrated or otherwise qualifiedInadequate archives and retrieval processes

    In 1976, the FDA published a draft regulation on GLP and requested comments from interested parties.After the consultation period, the nal regulation was published in 1978 - This came into force in 1979.

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