CFR section
21 CFR 820.70(c): Production and process controls
PART 820-QUALITY SYSTEM REGULATION · Subpart G-Production and Process Controls
Key facts
| Citation | 21 CFR 820.70(c) |
|---|---|
| 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) | (c) Environmental control. Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions. Environmental control system(s) shall be periodically inspected to verify that the system, including necessary equipment, is adequate and functioning properly. These activities shall be documented and reviewed. |
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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.