CFR section
21 CFR 820.70(g)(1): Production and process controls
PART 820-QUALITY SYSTEM REGULATION · Subpart G-Production and Process Controls
Key facts
| Citation | 21 CFR 820.70(g)(1) |
|---|---|
| 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 | Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented. |
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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.