good laboratory practice cfr 21 part 58 a review for ocra us rac study group september 2005 ginger...
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Good Laboratory PracticeCFR 21 Part 58
A Review for OCRA US RAC Study GroupSeptember 2005
Ginger Clasby, MSPromedica [email protected] 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