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Good Laboratory Practice CFR 21 Part 58

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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_at_promedica-intl.com – PowerPoint PPT presentation

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Title: Good Laboratory Practice CFR 21 Part 58


1
Good Laboratory Practice CFR 21 Part 58
A Review for OCRA US RAC Study Group September
2005 Ginger Clasby, MS Promedica
International gclasby_at_promedica-intl.com 714-7
99-1617 x 25
2
GLP What It Is
  • Describes good practices for non-clinical lab
    studies that support research or marketing
    approvals for FDA-regulated products

3
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

4
GLP Facilities Requirements
  • Suitable size, construction, segregation
  • Animal care
  • Animal supplies
  • Test control products maintained in a secure
    area
  • Operating suite
  • Specimen data storage

5
GLP Equipment Requirements
  • Appropriately designed
  • Adequate thru-put capacity
  • Appropriately located
  • Routinely maintained calibrated

6
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

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

8
GLP Reagents Solutions
  • Adequate labeling
  • Identity
  • Concentration
  • Storage requirements
  • Expiration date

9
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

10
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

11
GLP Study Implementation
  • Standard data capture/recording requirements
  • Legibility
  • Permanence
  • Accountability
  • Changes

12
GLP Records 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
GLP Records 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
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

15
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/Defa
    ult.htm
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