GroundRules
21 CFR 320.35: Requirements for in vitro testing of each batch.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
- Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON