Good Laboratory Practice CFR 21 Part 58

1. Good Laboratory PracticeCFR 21 Part 58 A Review for OCRA US RAC Study GroupSeptember 2005Ginger Clasby, MS Promedica Internationalgclasby@promedica-intl.com 714-799-1617 x 25

2. GLPWhat It Is • Describes good practices for non-clinical lab studies that support research or marketing approvals for FDA-regulated products

3. 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

4. GLPFacilities Requirements • Suitable size, construction, segregation • Animal care • Animal supplies • Test & control products maintained in a secure area • Operating “suite” • Specimen & data storage

5. GLPEquipment Requirements • Appropriately designed • Adequate thru-put capacity • Appropriately located • Routinely maintained & calibrated

6. 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

7. GLPStandard Operating Procedures • Collection & ID of specimens • Histopathology • Data handling, storage & retrieval • Equipment maintenance & calibration • Transfer, proper placement & ID of animals

8. GLPReagents & Solutions • Adequate labeling • Identity • Concentration • Storage requirements • Expiration date

9. GLPTest & Control Articles • Adequate characterization • Proper receipt, storage, distribution • When mixed with a carrier, adequate methods to confirm • Mixture uniformity • Article concentration • Article stability

10. 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

11. GLPStudy Implementation • Standard data capture/recording requirements • Legibility • Permanence • Accountability • Changes

12. 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

13. 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

14. 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

15. GLPReference 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