21 CFR 820.40 - Document Controls (QMSR)

What it says

Manufacturers must establish procedures to control documents required by the quality system, including review and approval by designated individuals before issuance, and a means to ensure changes to documents are reviewed and approved by the same function or organisation that performed the original review, with obsolete documents promptly removed from all points of use.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Document approval authority for a change must sit with the same function that approved the original document, preventing a change from being pushed through by a different, potentially less qualified function bypassing the original review expertise.
• Prompt removal of obsolete documents from points of use is explicit and specific, mirroring the same principle behind label control under 21 CFR 211.122 - an outdated document physically accessible at the point of use creates real risk regardless of its formal obsolete status elsewhere.
• Document control extends across the full quality system, not just manufacturing procedures, covering specifications, work instructions and quality records generally.

What FDA inspectors look for

• Whether document changes are approved by the same function that approved the original document, not routed around that expertise for convenience.
• Whether obsolete documents are genuinely removed from points of use during a facility walkthrough, not just formally superseded in a document management system while old copies remain accessible.
• Whether document approval records clearly identify who approved what and when, with a traceable history of revisions.

Related regulations