[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.111]

[Page 150]
 
                        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 F_Production and Process Controls
 
Sec.  211.111  Time limitations on production.

    When appropriate, time limits for the completion of each phase of 
production shall be established to assure the quality of the drug 
product. Deviation from established time limits may be acceptable if 
such deviation does not compromise the quality of the drug product. Such 
deviation shall be justified and documented.