[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: 21CFR226.1]

[Page 144]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 226.1  Current good manufacturing practice.


    The criteria in Secs. 226.10 through 226.115, inclusive, shall apply 
in determining whether the methods used in, or the facilities and 
controls used for the manufacture, processing, packing, or holding of a 
Type A medicated article(s) conform to or are operated or administered 
in conformity with current good manufacturing practice to assure that a 
Type A medicated article(s) meets the requirements of the act as to 
safety, and has the identity and strength, and meets the quality and 
purity characteristics which it purports or is represented to possess, 
as required by section 501(a)(2)(B) of the act. The regulations in this 
part 226 permit the use of precision, automatic, mechanical, or 
electronic equipment in the production of a Type A medicated article(s) 
when adequate inspection and checking procedures or other quality 
control procedures are used to assure proper performance.