A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68 , just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.182 Equipment cleaning and use log
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 § 211.182
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).
- Written records kept in individual logs 222
- Personnel dating/signing equipment log 45
- Specific information required in individual logs 43
- Dedicated equipment: records part of batch record 9
- Chronological Order of Equipment Log Entries 5
Warning letters citing § 211.182
9 FDA warning letters since 2017 cite this section :
- Fareva Amboise 10 Apr 2026
- Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi 12 Mar 2025
- Eurosirel S.P.A 20 Nov 2024
- Aerosol and Liquid Packaging, Inc. 24 Jul 2024
- Drivergent, Inc. 1 May 2023
- Product Packaging West, Inc. 2 Nov 2018
- Cerno Pharmaceutical 15 May 2018
- Wuxi Medical lnstrument Factory 7 Sept 2017
- US Stem Cell Clinic, LLC 24 Aug 2017
FDA guidance that cites § 211.182
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
- Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry 13 Dec 2018
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014
Amendment history
Federal Register documents that created or amended this section.
- 73 FR 51933 8 Sept 2008