CFR section
21 CFR 211.101(c): Charge-in of components
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart F-Production and Process Controls
Key facts
| Citation | 21 CFR 211.101(c) |
|---|---|
| Section | Charge-in of components |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart F-Production and Process Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (c) Weighing, measuring, or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that: (1) The component was released by the quality control unit; (2) The weight or measure is correct as stated in the batch production records; (3) The containers are properly identified. If the weighing, measuring, or subdividing operations are performed by automated equipment under § 211.68… |
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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.