CFR section
21 CFR 212.40(a): How must I control the components I use to produce PET drugs and the containers and closures I package them in?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart E-Control of Components, Containers, and Closures
Key facts
| Citation | 21 CFR 212.40(a) |
|---|---|
| Section | How must I control the components I use to produce PET drugs and the containers and closures I package them in? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart E-Control of Components, Containers, and Closures |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (a) Written procedures. You must establish, maintain, and follow written procedures describing the receipt, login, identification, storage, handling, testing, and acceptance and/or rejection of components and drug product containers and closures. The procedures must be adequate to ensure that the components, containers, and closures are suitable for their intended use. |
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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.