CFR section
21 CFR 212.20(c): What activities must I perform to ensure drug quality?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart C-Quality Assurance
Key facts
| Citation | 21 CFR 212.20(c) |
|---|---|
| Section | What activities must I perform to ensure drug quality? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart C-Quality Assurance |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (c) Specifications and processes. You must approve or reject, before implementation, any initial specifications, methods, processes, or procedures, and any proposed changes to existing specifications, methods, processes, or procedures, to ensure that they maintain the identity, strength, quality, and purity of a PET drug. You must demonstrate that any change does not adversely affect the identity, strength, quality, or purity of any PET drug. |
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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.