The requirement is in Title 21 of the CFR. PART 820 -- QUALITY SYSTEM REGULATION.
Subpart G--Production and Process Controls
Sec. 820.75 Process validation.
(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).
(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 19-Nov-2019 20:08
From: Anonymous Member
Subject: sterilization
This message was posted by a user wishing to remain anonymous
What is FDA's requirement on EO sterilization for mixed loads?