8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 1/15
Good Laboratory Practice
CFR 21 Part 58
A Review for OCRA US RAC Study Group
September 2005
Ginger Clasby, MS
Promedica International [email protected]
714-799-1617 x 25
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 2/15
GLP
What It Is
� Describes good practices for non-clinical lab studies
that support research or marketing approvals for FDA-
regulated products
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 3/15
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
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 4/15
GLP
Facilities Requirements
� Suitable size, construction, segregation
± Animal care
± Animal supplies
± Test & control products maintained in a secure
area
± Operating ³suite´
± Specimen & data storage
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 5/15
GLP
Equipment Requirements
� Appropriately designed
� Adequate thru-put capacity
� Appropriately located
� Routinely maintained & calibrated
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 6/15
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
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 7/15
GLP
Standard Operating Procedures
� Collection & ID of specimens
� Histopathology
� Data handling, storage & retrieval
� Equipment maintenance & calibration
� Transfer, proper placement & ID of animals
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 8/15
GLP
Reagents & Solutions
� Adequate labeling
± Identity
± Concentration
± Storage requirements
± Expiration date
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 9/15
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
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 10/15
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
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 11/15
GLP
Study Implementation
� Standard data capture/recording requirements
± Legibility
± Permanence
± Accountability
± Changes
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 12/15
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
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 13/15
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
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 14/15
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
8/7/2019 Glp - Pmi Format
http://slidepdf.com/reader/full/glp-pmi-format 15/15
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/Default.htm
Top Related