[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.25]

[Page 118-119]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                  Subpart B--Organization and Personnel
 
Sec. 211.25  Personnel qualifications.

    (a) Each person engaged in the manufacture, processing, packing, or 
holding of a drug product shall have education, training, and 
experience, or any combination thereof, to enable that person to perform 
the assigned functions. Training shall be in the particular operations 
that the employee performs

[[Page 119]]

and in current good manufacturing practice (including the current good 
manufacturing practice regulations in this chapter and written 
procedures required by these regulations) as they relate to the 
employee's functions. Training in current good manufacturing practice 
shall be conducted by qualified individuals on a continuing basis and 
with sufficient frequency to assure that employees remain familiar with 
CGMP requirements applicable to them.
    (b) Each person responsible for supervising the manufacture, 
processing, packing, or holding of a drug product shall have the 
education, training, and experience, or any combination thereof, to 
perform assigned functions in such a manner as to provide assurance that 
the drug product has the safety, identity, strength, quality, and purity 
that it purports or is represented to possess.
    (c) There shall be an adequate number of qualified personnel to 
perform and supervise the manufacture, processing, packing, or holding 
of each drug product.