CFR section
21 CFR 820.70(a): Production and process controls
PART 820-QUALITY SYSTEM REGULATION · Subpart G-Production and Process Controls
Key facts
| Citation | 21 CFR 820.70(a) |
|---|---|
| Section | Production and process controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart G-Production and Process Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (a) General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include: (1) Documented instructions… |
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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.