§ 111.55
21 CFR Part 111 · Subpart E Requirement to Establish a Production and Process Control System
§ 111.55 What are the requirements to implement a production and process control system?
You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
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