Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter B - FOOD FOR HUMAN CONSUMPTIONPart 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
Section 111.55 - What are the requirements to implement a production and process control system?

21 C.F.R. § 111.55

Download
PDF
Current through September 30, 2024
Section 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.

21 C.F.R. § 111.55