1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter B - FOOD FOR HUMAN CONSUMPTION
  5. Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
  6. Subpart E - Requirement to Establish a Production and Process Control System
  7. 21 CFR § 111.55
21 CFR § 111.55
What are the requirements to implement a production and process control system?
June 25, 2020
CFR

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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§ 111.75 What must you do to determine whether specifications are met?
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§ 111.60 What are the design requirements for the production and process control system?

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