FDA CDER Inspections

Based on FDA Compliance Program Guidance Manual Program 7356.002, located here.

Based on the program, there are 6 “systems” an FDA inspector may look at:Quality System (change control, batch release, annual product review, validation, etc.)

  1. Facilities and Equipment System (maintenance, utilities)
  2. Materials System (quality control, raw materials, inventory control)
  3. Production System (process validation, in-process sampling and controls, manufacturing procedure)
  4. Packaging and Labeling System (packaging processes, label inspection, etc.)
  5. Laboratory Control System (procedures, testing, analytical methods)

An inspection will always look at the Quality System.  A full inspection typically looks at 3 or more additional systems. An abbreviated inspection may look at only one additional system.

One FDA auditor has said the three documents they always ask for first are: Quality Policy/Manual, Annual Product Review (APR), and Org. Chart.

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