5
Pages
CGT
Visual Inspection
Free
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What's in the report
Identified FDA records
A CGT-specific FDA webinar discussion and two clearly labeled drug-manufacturing examples. No facility prevalence estimate is made.
Guidance scope and limits
What FDA's December 2021 draft guidance says about visible-particulate inspection, qualification, and defect libraries, including its exclusion of subvisible particulates.
Readiness questions
GxP Frame's questions for reviewing inspection purpose, qualified conditions, defect libraries, inspector qualification, and quality oversight.
Source register
Identifiable FDA documents and page or section references for each source finding, with the limits of this qualitative review.