CFR section
21 CFR 610.12(d): Sterility
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart B-General Provisions
Key facts
| Citation | 21 CFR 610.12(d) |
|---|---|
| Section | Sterility |
| Part | PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS |
| Subpart | Subpart B-General Provisions |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (d) The sample. The sample must be appropriate to the material being tested, considering, at a minimum: (1) The size and volume of the final product lot; (2) The duration of manufacturing of the drug product; (3) The final container configuration and size; (4) The quantity or concentration of inhibitors, neutralizers, and preservatives, if present, in the tested material; (5) For a culture-based test method, the volume of test material that results in a dilution of the product that is not… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.