Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 2 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
/ 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 / § 111.60 What are the design requirements for the production and process control system?
§ 111.60 What are the design requirements for the production and process control system?
(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.