CFR section
21 CFR 600.11(h): Physical establishment, equipment, animals, and care
PART 600-BIOLOGICAL PRODUCTS: GENERAL · Subpart B-Establishment Standards
Key facts
| Citation | 21 CFR 600.11(h) |
|---|---|
| Section | Physical establishment, equipment, animals, and care |
| Part | PART 600-BIOLOGICAL PRODUCTS: GENERAL |
| Subpart | Subpart B-Establishment Standards |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (h) Containers and closures. All final containers and closures shall be made of material that will not hasten the deterioration of the product or otherwise render it less suitable for the intended use. All final containers and closures shall be clean and free of surface solids, leachable contaminants and other materials that will hasten the deterioration of the product or otherwise render it less suitable for the intended use. After filling, sealing shall be performed in a manner that will… |
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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.