CFR section

21 CFR 820.72(a): Inspection, measuring, and test equipment

PART 820-QUALITY SYSTEM REGULATION · Subpart G-Production and Process Controls

Key facts

Citation 21 CFR 820.72(a)
Section Inspection, measuring, and test equipment
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
Regulation text (excerpt) (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling…

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