[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: 21CFR211.100]

[Page 123]
 
                        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 F--Production and Process Controls
 
Sec. 211.100  Written procedures; deviations.


    (a) There shall be written procedures for production and process 
control designed to assure that the drug products have the identity, 
strength, quality, and purity they purport or are represented to 
possess. Such procedures shall include all requirements in this subpart. 
These written procedures, including any changes, shall be drafted, 
reviewed, and approved by the appropriate organizational units and 
reviewed and approved by the quality control unit.
    (b) Written production and process control procedures shall be 
followed in the execution of the various production and process control 
functions and shall be documented at the time of performance. Any 
deviation from the written procedures shall be recorded and justified.