21 CFR 211.100(a) - Written Procedures - Establishment and Adherence

What it says

Written procedures must be established for production and process control designed to assure that drug products have the identity, strength, quality and purity they purport to have, and those procedures must be followed. Any deviation from a written procedure must be documented and justified.

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

What it means in practice

• This provision is cited in two distinct ways: either a required procedure does not exist in writing at all, or a written procedure exists but was not followed during actual production.
• An undocumented deviation from a written procedure, even a well-intentioned one that did not affect product quality, is itself the violation - the procedure exists specifically so that departures from it are visible and controlled.
• Procedures must be specific enough to actually govern the activity. A procedure written in vague or generic terms that leaves the real operating parameters to informal practice does not satisfy this requirement.

What FDA inspectors look for

• Direct comparison between what a written procedure states and what batch records, logbooks or personnel interviews show actually happened.
• Whether undocumented deviations from procedure are a one-time event or a recurring, tolerated practice.
• Whether procedures are current, reflecting the process as actually operated, rather than an outdated version nobody has updated to match real practice.

Related regulations