A presentation that walks through the entire inspection process
https://www.fda.gov/media/92857/download
Form 482
The “official notice” that an FDA inspection will take place
21 CFR 211
A detailed list of Good Manufacturing Practice for pharma
CFR 111
A detailed list of Good Manufacturing Practice for supplements
Form FDA 4003
A request for specific records
ALCOA Standards for source data
Stands for “Attributable. Legible. Contemporaneous. Original”
Compliance Inspection guides
Provide directions for how an inspector should conduct an inspection and what to look for Investigations Operation Manual Serves as overall guideline in conducting inspections. Although primarily an internal resource, becoming familiar with the IOM may better prepare one for an inspection.
CGMP
Minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product
FDA Guidance Documents
A collection of standards specific to different products and manufacturing processes
Videos
The agency has posted several YouTube videos, including “FDA Drug Manufacturing Inspections”, “How Does FDA Execute Preand Post-Approval Inspections”, and “Walkthrough of a PreApproval Manufacturing Site Inspection”
FDA Data Dashboard
Provides examples to common inspection citations in drug facility inspections https://datadashboard.fda.gov/ora/index.htm
Warning Letters or Advisory Action Letters
Lists necessary corrective actions that, if unmet, could lead to enforcement
Current Guidance for Drug Manufacturers
https://www.fda.gov/regulatory-information/search-fdaguidance-documents).
Drug Shortages: Root Causes and Potential Problems
A report examining factors leading to drug shortages and presents possible solutions
Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals
White Paper examining supply chain issues that could affect drug quality