CFR section
21 CFR 212.30(b): What requirements must my facilities and equipment meet?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart D-Facilities and Equipment
Key facts
| Citation | 21 CFR 212.30(b) |
|---|---|
| Section | What requirements must my facilities and equipment meet? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart D-Facilities and Equipment |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (b) Equipment procedures. You must implement procedures to ensure that all equipment that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained, is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results. You must document your activities in accordance with these procedures. |
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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.