Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under § 211.68 , be independently verified by one person.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.103 Calculation of yield
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 § 211.103
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).
- Actual vs. theoretical yields not determined 151
- Yield calculations not verified by 2nd person 18
Warning letters citing § 211.103
1 FDA warning letters since 2017 cite this section :
- Pine Pharmaceuticals, LLC 7 Aug 2026
FDA guidance that cites § 211.103
- 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for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
- Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff 11 Jan 2017
- Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff 1 Dec 2007
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 2 Oct 2006
Amendment history
Federal Register documents that created or amended this section.
- 73 FR 51932 8 Sept 2008