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FDA Audit Preparation

How to prepare for FDA audit?

Specially for PAI?

@ariyan

You can check the below points (not limited to):

  • Document control system
  • In-process control
  • Finished product control
  • Deviation, OOS & OOT management
  • Previous audit observation etc.

Details: https://www.pharmaspecialists.com/2022/11/fda-inspection-checklist.html