[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: 21CFR211.103]

[Page 148-149]
 
                        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.  211.103  Calculation of yield.

    Actual yields and percentages of theoretical yield shall be 
determined at the conclusion of each appropriate phase of manufacturing, 
processing,

[[Page 149]]

packaging, or holding of the drug product. Such calculations shall be 
performed by one person and independently verified by a second person.

    Effective Date Note: At 72 FR 68069, Dec. 4, 2007, Sec.  211.103 was 
revised, effective Apr. 17, 2008. For the convenience of the user, the 
revised text is set forth as follows:


 
                        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.  211.103  Calculation of yield.

    Actual yields and percentages of theoretical yield shall be 
determined at the conclusion of each appropriate phase of manufacturing, 
processing, packaging, or holding of the drug product. Such calculations 
shall either be performed by one person and independently verified by a 
second person, or, if the yield is calculated by automated equipment 
under Sec.  211.68, be independently verified by one person.