FDA Inspection Response Report

Inspection Response Program or IRP is a written policy and procedures of issues pertaining to inspection.
  • It ensures all relevant policies will be well thought out.
  • Senior members of company management will approve both the policy and their implementation.
  • SOP's are written. They are communicated to all who are involved in hosting regulatory inspectors. Hence you ensure uniform application of such policies throughout the firm.

And then it also provides a basis for periodic review as regulations and other practice change thorough out the year.

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The FDA Inspection Process: From SOP to 483