FDA Intel

21 CFR 211.103: Calculation of yield

Requires manufacturers to determine actual yield and percent of theoretical yield at the end of each appropriate manufacturing, processing, packaging, or holding phase, with calculations independently verified by a second person, or by one person if automated.

Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart F, Production and Process Controls

How FDA words it

The opening lines investigators use most when they cite 211.103, from the 483s we hold.

Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.Most used

Cited over time

483s citing 211.103, by year

Most citations in 2022. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2022.

Recent 483s citing 211.103

See all 483s citing 211.103

The regulation text

§ 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]

Questions

What does 21 CFR 211.103 require?

Requires manufacturers to determine actual yield and percent of theoretical yield at the end of each appropriate manufacturing, processing, packaging, or holding phase, with calculations independently verified by a second person, or by one person if automated.

How do FDA investigators word a 211.103 observation?

The most common opening is: “Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.”

Which sections are cited alongside 211.103?

In the same 483s, investigators most often also cite 211.100 (Written procedures; deviations), 211.22 (Responsibilities of quality control unit), 211.160 (General requirements), 211.192 (Production record review).