CFR section
21 CFR 211.34: Consultants
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart B-Organization and Personnel
Key facts
| Citation | 21 CFR 211.34 |
|---|---|
| Section | Consultants |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart B-Organization and Personnel |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide. |
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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.