I think you will find what you're looking for in the document
Quality System Information for Certain Premarket Application Reviews dated 2003.
The section on process validation begins:
Process Validation, 820.75
7. You should provide a copy of your process validation master plan, or a description of
which manufacturing processes you will validate, for the device under review.
Provide a list of processes for the device under review that you do not plan to validate
but will verify by inspection and test.
------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States
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Original Message:
Sent: 29-Sep-2021 14:41
From: Anonymous Member
Subject: Submit Process Qualification Protocols in PMA only
This message was posted by a user wishing to remain anonymous
I had come across a guidance document from FDA which allows manufacturers to submit their manufacturing module only with PQ protocol and then FDA can review the report as a part of the Pre-Approval Inspection (PAI). However, I cannot find which guidance covers this strategy.
I have been trying to find this since 3 days but no luck. I am reaching out to my regulatory community if they can help me locate this in any FDA guidance.