21 C.F.R. § 211.103

Calculation of yield.

Last amended: 2016Year: 2026Length: 67 wordsOfficial source

Cite as 21 C.F.R. § 211.103 (2026)

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. [73 FR 51932, Sept. 8, 2008]
Cross-references to the CFR
211.68
21 C.F.R. § 211.103: Calculation of yield. | Justis AI