Good Laboratory PracticeCFR 21 Part 58

A Review for OCRA US RAC Study GroupSeptember 2005

Ginger Clasby, MSPromedica Internationalgclasby@promedica-intl.com714-799-1617 x 25

GLPWhat It Is

• Describes good practices for non-clinical lab studies that support research or marketing approvals for FDA-regulated products

GLPGeneral 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

GLPFacilities Requirements

• Suitable size, construction, segregation– Animal care

– Animal supplies

– Test & control products maintained in a secure area

– Operating “suite”

– Specimen & data storage

GLPEquipment Requirements

• Appropriately designed

• Adequate thru-put capacity

• Appropriately located

• Routinely maintained & calibrated

GLPStandard 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

GLPStandard Operating Procedures

• Collection & ID of specimens

• Histopathology

• Data handling, storage & retrieval

• Equipment maintenance & calibration

• Transfer, proper placement & ID of animals

GLPReagents & Solutions

• Adequate labeling– Identity

– Concentration

– Storage requirements

– Expiration date

GLPTest & Control Articles

• Adequate characterization

• Proper receipt, storage, distribution

• When mixed with a carrier, adequate methods to confirm

– Mixture uniformity

– Article concentration

– Article stability

GLPStudy 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

GLPStudy Implementation

• Standard data capture/recording requirements– Legibility

– Permanence

– Accountability

– Changes

GLPRecords & Reports

• Final report of results• Study records & data methodically archived to

facilitate expedient retrieval– Study documents– Raw data– Specimens– Protocols– QA inspections– Personnel training & qualifications– Calibration & maintenance records

GLPRecords & Reports

• Records retention (shortest of):– ≥ 2 yr after FDA 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

GLPFacility Disqualification

• Grounds for disqualification:– Failure to comply with regulations &

– Noncompliance adversely affects study validity &

– Previous regulatory actions have been unsuccessful in modifying facility operations

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

• 21 CFR 58 – Good Laboratory Practice for Non-clinical Laboratory Studies

• Div. of Scientific Investigations: Good Laboratory Practicewww.fda.gov/cder/Offices/DSI/goodLabPractice.htm

• BIMO Compliance Program Guidance 7348.808A: GLP Programwww.fda.gov/ora/compliance_ref/bimo/7348_808A/Default.htm