[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.60]

[Page 237]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
  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?

    (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.