§211.103. Calculation of yield.
21 C.F.R. § 211.103
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.
Notes, amendments, and revision history
Amendments
[73 FR 51932, Sept. 8, 2008]
Authority
Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
Source
Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.
Amendments
[73 FR 51932, Sept. 8, 2008]