CFR section
21 CFR 820.40(a): Document controls
PART 820-QUALITY SYSTEM REGULATION · Subpart D-Document Controls
Key facts
| Citation | 21 CFR 820.40(a) |
|---|---|
| Section | Document controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart D-Document Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete… |
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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.