If a bioequivalence requirement specifies a currently available in vitro test or an in vitro bioequivalence standard comparing the drug product to a reference standard, the manufacturer shall conduct the test on a sample of each batch of the drug product to assure batch-to-batch uniformity.
21 CFR Part 320 · Bioavailability and Bioequivalence Requirements
§ 320.35 Requirements for in vitro testing of each batch
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Amendment history
Federal Register documents that created or amended this section.
- 42 FR 1635 7 Jan 1977
- 57 FR 18001 28 Apr 1992