CFR section
21 CFR 211.122(g): Materials examination and usage criteria
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart G-Packaging and Labeling Control
Key facts
| Citation | 21 CFR 211.122(g) |
|---|---|
| Section | Materials examination and usage criteria |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart G-Packaging and Labeling Control |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (g) If cut labeling is used for immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons, packaging and labeling operations shall include one of the following special control procedures: (1) Dedication of labeling and packaging lines to each different strength of each different drug product; (2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for… |
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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.