Tag: 21 CFR Part 820


21 CFR 820.70 Production and Process Controls

21 CFR PART 820 QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls 820.70 Production and process controls (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

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