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Title 21 Part 111 → Subpart E → §111.60

Title 21 → Chapter I → Subchapter B → Part 111 → Subpart E → §111.60

Electronic Code of Federal Regulations e-CFR

Title 21 Part 111 → Subpart E → §111.60

§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.