CFR section
21 CFR 212.60(g): What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart G-Laboratory Controls
Key facts
| Citation | 21 CFR 212.60(g) |
|---|---|
| Section | What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart G-Laboratory Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (g) Test records. Each laboratory performing tests related to the production of a PET drug must keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays, as follows: (1) A suitable identification of the sample received for testing. (2) A description of each method used in the testing of the sample, a record of all calculations performed in connection with each test, and a statement of the weight or… |
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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.