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21 CFR Part 820 · Quality Management System Regulation

§ 820.75 Process validation

Subpart G - Production and Process Controls Official text on eCFR
Removed from 21 CFR. The Quality Management System Regulation (QMSR) replaced the Quality System Regulation on 2 Feb 2026. Removed by the Quality Management System Regulation, effective 2 February 2026: Part 820 now incorporates ISO 13485:2016 by reference (§ 820.7) and requires it in § 820.10. See § 820.10. The text below is the former QSR wording, kept for reference.

(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. Subpart H—Acceptance Activities

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 820.75

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Devices).

  • Lack of or inadequate process validation 1,449
  • Documentation 426
  • Lack/Inad procedure-Monitoring/Control of Validated Proces 264
  • Process changes - review, evaluation and revalidation 142
  • Documentation of validated process performance 88
  • Documentation - review in response to changes or deviations 61

Warning letters citing § 820.75

97 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 820.75