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Good Laboratory Practice

CFR 21 Part 58 

 A Review for OCRA US RAC Study Group

September 2005 

Ginger Clasby, MS 

Promedica International gclasby@promedica-intl.com

714-799-1617 x 25 

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GLP 

What It Is

� Describes good practices for non-clinical lab studies

that support research or marketing approvals for FDA-

regulated products

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GLP 

General Requirements

�  Appropriately qualified personnel 

�  Adequate resources

�  Appropriate procedures for:

 ± Sanitation, health precautions, clothing

 ± Test protocol development, test methods

 ± Data analysis, report development 

�  Appropriately qualified study director 

� Quality assurance function

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GLP 

Facilities Requirements

� Suitable size, construction, segregation

 ±  Animal care

 ±  Animal supplies

 ± Test & control products maintained in a secure

area

 ± Operating ³suite´ 

 ± Specimen & data storage

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GLP 

Equipment Requirements

�  Appropriately designed 

�  Adequate thru-put capacity 

�  Appropriately located 

� Routinely maintained & calibrated 

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GLP 

Standard Operating Procedures

�  Animal room prep

�  Animal care

� Receipt, ID, storage, handling, mixing & sampling of test & control articles

� Test system observations

� Lab tests

� Handling of moribund or dead animals

� Necropsy or postmortem exams of animals

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GLP 

Standard Operating Procedures

� Collection & ID of specimens

� Histopathology 

� Data handling, storage & retrieval 

� Equipment maintenance & calibration

� Transfer, proper placement & ID of animals

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GLP 

Reagents & Solutions

�  Adequate labeling

 ± Identity 

 ± Concentration

 ± Storage requirements

 ± Expiration date

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GLP 

Test & Control Articles

�  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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GLP 

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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GLP 

Study Implementation

� Standard data capture/recording requirements

 ± Legibility 

 ± Permanence

 ±  Accountability 

 ± Changes

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GLP 

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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GLP 

Records & Reports

� Records retention (shortest of):

 ± � 2 yr after FDA marketing clearance

 ± � 5 yr after data submitted to FDA in support of marketingapplication

 ± � 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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GLP 

Facility Disqualification

� 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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GLP 

Reference Documents & Links ( www.fda.gov/cder  )

� 21 CFR 58 ± Good Laboratory Practice for Non-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