[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.103]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F – Production and Process Controls
Sec. 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]
As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.