§ 211.103 Calculation of yield.
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]
How BatchGlow handles this
When a compounded batch is completed, its actual yield is calculated against the expected yield, and a yield outside its limits opens a deviation and holds the bulk.
What it asks for, in plain words
- 21 CFR 211.103
- The actual yield and the percentage of theoretical yield are determined at the end of each appropriate phase. One person calculates and a second verifies; a yield calculated by automated equipment is verified by one person.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.