CFR section
21 CFR 212.50(c): What production and process controls must I have?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart F-Production and Process Controls
Key facts
| Citation | 21 CFR 212.50(c) |
|---|---|
| Section | What production and process controls must I have? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart F-Production and Process Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (c) Batch production and control records. Each time a batch of a PET drug is produced, a unique batch production and control record must be created. The batch production record must include the following information: (1) Name and strength of the PET drug; (2) Identification number or other unique identifier of the specific batch that was produced; (3) The name and radioactivity or other measure of each active pharmaceutical ingredient and each inactive ingredient per batch or per unit of… |
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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.