[Code of Federal Regulations] |
[Title 21, Volume 2] |
[Revised as of April 1, 2020] |
[CITE: 21CFR111.60] |
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CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION |
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PART 111 -- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Subpart E - Requirement to Establish a Production and Process Control System
Sec. 111.60 What are the design requirements for the production and process control system?
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(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and
(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel.
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