CFR section
21 CFR 211.194(a): Laboratory records
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 211.194(a) |
|---|---|
| Section | Laboratory records |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Veterinary |
| Regulation text (excerpt) | (a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: (1) A description of the sample received for testing with identification of source (that is, location from where sample was obtained), quantity, lot number or other distinctive code, date sample was taken, and date sample was received for testing. (2) A statement of each method used in the testing of… |
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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.