CFR section
21 CFR 212.61(a): What must I do to ensure the stability of my PET drug products through expiry?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart G-Laboratory Controls
Key facts
| Citation | 21 CFR 212.61(a) |
|---|---|
| Section | What must I do to ensure the stability of my PET drug products through expiry? |
| 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) | (a) Stability testing program. You must establish, follow, and maintain a written testing program to assess the stability characteristics of your PET drug products. The test methods must be reliable, meaningful, and specific. The samples tested for stability must be representative of the lot or batch from which they were obtained and must be stored under suitable conditions. |
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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.