CFR section
21 CFR 226.40(f): Production and control procedures
PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES · Subpart C-Product Quality Control
Key facts
| Citation | 21 CFR 226.40(f) |
|---|---|
| Section | Production and control procedures |
| Part | PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES |
| Subpart | Subpart C-Product Quality Control |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (f) If there is sequential production of batches of a Type A medicated article(s) containing the same drug component (or components) at the same or lower levels, there shall be sufficient safeguards to avoid any buildup above the specified levels of the drug components in any of the batches of the Type A medicated article(s). |
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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.