CFR section
21 CFR 600.12(a): Records
PART 600-BIOLOGICAL PRODUCTS: GENERAL · Subpart B-Establishment Standards
Key facts
| Citation | 21 CFR 600.12(a) |
|---|---|
| Section | Records |
| Part | PART 600-BIOLOGICAL PRODUCTS: GENERAL |
| Subpart | Subpart B-Establishment Standards |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | (a) Maintenance of records. Records shall be made, concurrently with the performance, of each step in the manufacture and distribution of products, in such a manner that at any time successive steps in the manufacture and distribution of any lot may be traced by an inspector. Such records shall be legible and indelible, shall identify the person immediately responsible, shall include dates of the various steps, and be as detailed as necessary for clear understanding of each step by one… |
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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.