Lab Inspection Preparation Checklist 1
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Lab Inspection Preparation Checklist 1 |
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Operations and Systems
Compliance self assessment completed
Mock audit completed
Corrective actions from previous inspections
completed
All FDA questions about items in regulatory
submissions answered
List of commitments in regulatory submissions
generated
All commitments in regulatory submissions being
met
All OOS investigations closed out
Trending systems in place
passing results
OOS results
SST failures
stability
raw materials and components
environmental monitoring
Stability trending requires FDA notification
Each raw material and component has a specific
identity test
If reduced testing is being used: reliability
of vendors analyses has been confirmed by completing all Certificate of
Analysis Tests recently (within last 1-2 years)
Contract analytical firms have been audited
Lists of possible questions and answers have
been generated and studied
EIRS, 483s, Warning Letters from inspections
of similar firms/products have been obtained and studied
Literature searches regularly conducted and
relevant papers circulated to appropriate personnel
Key newsletters (e.g. BioQuality, GMP Trends,
the Gold Sheet) circulated to appropriate personnel
Inspection host and backup identified and trained More to come next week! |
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Office: 916-729-0109 |
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