[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.22]

[Page 116-117]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
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

[[Page 117]]

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.