A great reference for ensuring you are audit ready are the FDA’s Guide to Inspections documents and Guidance for Industry documents.

The FDA Inspection guides are freely available from here.

For my own reference and review, I’ve saved some of the Guidance for Industry documents below.  However, you can get them all from this link.

• guidance for industry – investigating OOS test results for pharmaceutical production
• Guidance for Industry – general validation principles
• guidance for industry – q7a GMP for APII
• FDA-270-Guidance for Industry Sterile Drug Products Produced by Aseptic Processing
• FDA Guide to Inspections of HPW 4-27-07
• FDA guidance for industry – sterile drug products produced by aseptic processing

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