[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.22]

[Page 118]
 
                        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. 211.22  Responsibilities of quality control unit.


    (a) There shall be a quality control unit that shall have the 
responsibility and authority to approve or reject all components, drug 
product containers, closures, in-process materials, packaging material, 
labeling, and drug products, and the authority to review production 
records to assure that no errors have occurred or, if errors have 
occurred, that they have been fully investigated. The quality control 
unit shall be responsible for approving or rejecting drug products 
manufactured, processed, packed, or held under contract by another 
company.
    (b) Adequate laboratory facilities for the testing and approval (or 
rejection) of components, drug product containers, closures, packaging 
materials, in-process materials, and drug products shall be available to 
the quality control unit.
    (c) The quality control unit shall have the responsibility for 
approving or rejecting all procedures or specifications impacting on the 
identity, strength, quality, and purity of the drug product.
    (d) The responsibilities and procedures applicable to the quality 
control unit shall be in writing; such written procedures shall be 
followed.