[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.113]

[Page 143]
 
                        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--
 
                Subpart F_Production and Process Controls
 
Sec.  211.113  Control of microbiological contamination.

    (a) Appropriate written procedures, designed to prevent 
objectionable microorganisms in drug products not required to be 
sterile, shall be established and followed.
    (b) Appropriate written procedures, designed to prevent 
microbiological contamination of drug products purporting to be sterile, 
shall be established and followed. Such procedures shall include 
validation of any sterilization process.

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