CFR section
21 CFR 226.40(d): 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(d) |
|---|---|
| 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) | (d) Competent and responsible personnel shall check actual against theoretical yield of a batch of Type A medicated article(s), and, in the event of any significant discrepancies, key personnel shall prevent distribution of the batch in question and other associated batches of Type A medicated article(s) that may have been involved in a mixup with it. |
At a glance
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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.