CFR section
21 CFR 820.40(b): Document controls
PART 820-QUALITY SYSTEM REGULATION · Subpart D-Document Controls
Key facts
| Citation | 21 CFR 820.40(b) |
|---|---|
| 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 |
| Regulation text (excerpt) | (b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the… |
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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.