the abcs of the glps - revised

8/6/2019 The ABCs of the GLPs - Revised

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The ABCs of the GLPs

Stacy Pritt, DVM, MBA, MS


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Ou tline

GL PsWhere can you get further information?

You get to play QA!


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The GLPs

GL Ps = G ood Laboratory PracticesFederal regulations that describe how to

conduct nonclinical laboratory studies thatsupport or are intended to supportapplications for research or marketingpermits for products regulated by the Foodand Drug Administration


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GLP St ud ies Are NecessaryFor The Following Pro du cts:

Food and color additives

Animal food additivesHuman and animaldrugsMedical devices

Biological productsElectronic products


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FDA GLPs Come From:

Federal Food, Drug, and Cosmetic ActOriginally implemented in 1978

Updated periodicallyFDA is enforcing agency


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Also Incl ud es.

Some products (pesticides, insecticides, etc.)regulated by the EPA


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W hy the GLPs?

Problems in the past:Some safety assessments were based on poor quality studiesStudy protocols and records were not alwayslocatedDetails of procedures were inadequate

Qualifications of personnel and training recordswere not always available


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The GLPs

Code of FederalRegulationsTitle 21 Food andDrugsPart 58 G oodLaboratory Practices for Nonclinical LaboratoryStudies


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Basic Req u irements

Study ProtocolsStandard Operating Procedures (SOPs)

Trained personnel familiar with the testingmethodologies Adequate facilities and equipment, equipmentmaintenance

Full identification of test substanceProper Animal Care (vs. Animal Welfare)

Accurate recording of observations and reportingof results


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Basic Definitions

Nonclinical laboratory study In vivo or In vitroexperiments in which test articles are studiedprospectively in test systems under laboratory

conditions to determine their safety; does notinclude human studies, animal field trials, or chemical testsStudy Director Individual responsible for theoverall conduct of a nonclinical laboratory studySponsor

Initiator (by financial or other resources) of a nonclinicalstudySubmitter of a study to the FDA

Testing facility if it initiates and conducts the study


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Basic Definitions

Quality Assurance Unit Any person or organizational element (except SD)

designated by the testing facilitymanagement to perform the qualityassurance of a nonclinical laboratory studyProtocol Procedures for the study


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Basic Definitions

Test System Animal, plant, microorganisms, or subpartsreceiving administration of test or control article

Test Article Any article subject to regulationunder the FDAControl Article Article administered to a testsystem for the purpose of establishing abasis for comparison with the test articleTesting Facility Facility that conducts anonclinical study and is required to register

with the FDA


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Basic Definitions

Raw DataLaboratory worksheets

RecordsMemorandaNotesOr exact copies that are the result of original

observations and activities of the study necessaryfor the reconstruction and evaluation of the reportof that study

Animal cage cards?


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Areas of the GLP Reg u lations

G eneral Provisions, Organization, &Personnel

Facilities & EquipmentTesting Facility Operations andTest, Control, and Reference

SubstancesProtocol for the Conduct of a Study, Reports,and Records


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Life Cycle of a GLP St ud y

Protocol Report

QAU

Study Director, Testing Facility Management

FDA/EPA

Sponsor

Nonclinical Laboratory Study


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Sponsors & Facilities

Sponsors have a product they want to sellLarge Pharma

Medical DeviceStart-up biotech/pharma

Sponsors may not be the testing acility if:They have inadequate facilities and/or expertiseWant independent verification of their dataThe FDA has required them to seek an outsideopinion

Contract Research Organizations


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Responsibilities

Study Director Protocol approval (including changes anddeviations during the course of the study)

Accurate experimental data recording andverificationGL P standards are followed

Submission of raw data, documentation,protocols, specimens, and final reports or archives at end of study


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Responsibilities

QAUMaintain a master schedule of all studiesconducted at the testing facilityMaintain all protocols and SOPsConduct inspections of studies to ensure integrityReview study reports for accuracy


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FacilitiesSeparate areas for:

Receipt and storage of test, control, andreference substances

Conducting proceduresStorage of raw dataSeparation of animal species

Animal food and bedding storage Animal food mixing


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E q u ipmentEquipment shall be inspected, cleaned, andmaintained on a regular basisEquipment used for the generation,measurement, or assessment of data shall beadequately tested, calibrated, and maintainedWritten records of all testing, calibrating, and

inspections shall be maintained


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S O Ps

Animal Care Animal room maintenance

Test system preparation and receiptReceipt, identification, storage, and mixing of test, control, and reference substances

NecropsyCollection and identification of specimensMaintenance and calibration of equipment


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Animal Care

SOPs for the housing, feeding, and care of animals must be maintainedSome requirements are:

New animals must be quarantined or isolated andtheir health status evaluated prior to use

Animals must be identified appropriately All housing areas must be kept clean andsanitized regularlyFeed and water should be analyzed periodically(every 6 months) and contaminant levelsmonitored and documented


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M ore Information

FDA Web siteEPA Web site

Society for Regulatory Affairs Professionals AAL AS


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Y o u Play QA!

Read the Protocol

See what is wrong on the data sheet

the abcs of the glps - revised

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