[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: 21CFR211.101]

[Page 148]
 
                        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.  211.101  Charge-in of components.

    Written production and control procedures shall include the 
following, which are designed to assure that the drug products produced 
have the identity, strength, quality, and purity they purport or are 
represented to possess:
    (a) The batch shall be formulated with the intent to provide not 
less than 100 percent of the labeled or established amount of active 
ingredient.
    (b) Components for drug product manufacturing shall be weighed, 
measured, or subdivided as appropriate. If a component is removed from 
the original container to another, the new container shall be identified 
with the following information:
    (1) Component name or item code;
    (2) Receiving or control number;
    (3) Weight or measure in new container;
    (4) Batch for which component was dispensed, including its product 
name, strength, and lot number.
    (c) Weighing, measuring, or subdividing operations for components 
shall be adequately supervised. Each container of component dispensed to 
manufacturing shall be examined by a second person to assure that:
    (1) The component was released by the quality control unit;
    (2) The weight or measure is correct as stated in the batch 
production records;
    (3) The containers are properly identified.
    (d) Each component shall be added to the batch by one person and 
verified by a second person.

    Effective Date Note: At 72 FR 68069, Dec. 4, 2007, Sec.  211.101 was 
amended by revising paragraphs (c) and (d), 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.  211.101  Charge-in of components.

                                * * * * *

    (c) Weighing, measuring, or subdividing operations for components 
shall be adequately supervised. Each container of component dispensed to 
manufacturing shall be examined by a second person to assure that:
    (1) The component was released by the quality control unit;
    (2) The weight or measure is correct as stated in the batch 
production records;
    (3) The containers are properly identified. If the weighing, 
measuring, or subdividing operations are performed by automated 
equipment under Sec.  211.68, only one person is needed to assure 
conditions of paragraphs (c)(1), (c)(2), and (c)(3) of this section have 
been met.
    (d) Each component shall either be added to the batch by one person 
and verified by a second person or, if the components are added by 
automated equipment under Sec.  211.68, only verified by one person.