When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.111 Time limitations on production
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 § 211.111
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).
- Establishment of time limitations 192
- Deviations of production time limits 19
Warning letters citing § 211.111
6 FDA warning letters since 2017 cite this section :
- Utah Cord Bank LLC dba Utah Cell Bank 10 Aug 2021
- Cosmax USA, Inc. 15 Oct 2020
- Kadesh International 2 May 2019
- Medaus, Inc. 8 Mar 2018
- Lupin Limited 6 Nov 2017
- Pharmacy Plus, Inc. dba Vital Care Compounder 9 Aug 2017
FDA guidance that cites § 211.111
- Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry draft 29 Sept 2021
- 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for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
- Transdermal and Topical Delivery Systems - Product Development and Quality Considerations draft 21 Nov 2019
- 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
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 2 Oct 2006
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry 4 Oct 2004
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 45077 29 Sept 1978