[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: 21CFR111.12]

[Page 231]
 
                        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 B_Personnel
 
Sec.  111.12  What personnel qualification requirements apply?

    (a) You must have qualified employees who manufacture, package, 
label, or hold dietary supplements.
    (b) You must identify who is responsible for your quality control 
operations. Each person who is identified to perform quality control 
operations must be qualified to do so and have distinct and separate 
responsibilities related to performing such operations from those 
responsibilities that the person otherwise has when not performing such 
operations.
    (c) Each person engaged in manufacturing, packaging, labeling, or 
holding, or in performing any quality control operations, must have the 
education, training, or experience to perform the person's assigned 
functions.