CFR section
21 CFR 212.40(c): 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(c) |
|---|---|
| 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) | (c) Examination and testing. Upon receipt, each lot of components and containers and closures must be uniquely identified and tested or examined to determine whether the lot complies with your specifications. You must not use in PET drug production any lot that does not meet its specifications, including any expiration date if applicable, or that has not yet received its material release. Any incoming lot must be appropriately designated as quarantined, accepted, or rejected. You must use a… |
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