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21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals

§ 211.100 Written procedures; deviations

Subpart F - Production and Process Controls Official text on eCFR Amendment history

(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.

(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.

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 § 211.100

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

  • Absence of Written Procedures 1,420
  • SOPs not followed / documented 632
  • Procedure Deviations Recorded and Justified 248
  • Changes to Procedures Not Reviewed, Approved 185
  • Approval and review of procedures 170

Warning letters citing § 211.100

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

FDA guidance that cites § 211.100

and 23 more.

Amendment history

Federal Register documents that created or amended this section.