[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR226.40]

[Page 146-147]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES--Table of Contents
 
                   Subpart C--Product Quality Control
 
Sec. 226.40  Production and control procedures.


    Production and control procedures shall include all reasonable 
precautions, including the following, to assure that the Type A 
medicated article(s) produced have the identity, strength, quality, and 
purity they purport to possess:
    (a) Each critical step in the process, such as the selection, 
weighing, and measuring of components; the addition of drug components 
during the process; weighing and measuring during various

[[Page 147]]

stages of the processing; and the determination of the finished yield, 
shall be performed by one or more competent, responsible individuals. If 
such steps in the processing are controlled by precision, automatic, 
mechanical, or electronic equipment, their proper performance shall be 
adequately checked by one or more competent, responsible individuals.
    (b) All containers to be used for undiluted drugs, drug components, 
intermediate mixtures thereof, and Type A medicated article(s) shall be 
received, adequately identified, and properly stored and handled in a 
manner adequate to avoid mixups and contamination.
    (c) Equipment, including dust-control and other equipment, such as 
that used for holding and returning recovered or flush-out materials 
back into production, shall be maintained and operated in a manner to 
avoid contamination of the Type A medicated article(s) and to insure the 
integrity of the finished product.
    (d) Competent and responsible personnel shall check actual against 
theoretical yield of a batch of Type A medicated article(s), and, in the 
event of any significant discrepancies, key personnel shall prevent 
distribution of the batch in question and other associated batches of 
Type A medicated article(s) that may have been involved in a mixup with 
it.
    (e) Adequate procedures for cleaning of those parts of storage, 
mixing conveying and other equipment coming in contact with the drug 
component of the Type A medicated article(s) shall be used to avoid 
contamination of Type A medicated article(s).
    (f) If there is sequential production of batches of a Type A 
medicated article(s) containing the same drug component (or components) 
at the same or lower levels, there shall be sufficient safeguards to 
avoid any buildup above the specified levels of the drug components in 
any of the batches of the Type A medicated article(s).
    (g) Production and control procedures shall include provision for 
discontinuing distribution of any Type A medicated article(s) found by 
the assay procedures, or other controls performed to fail to conform to 
appropriate specifications. Distribution of subsequent production of 
such Type A medicated article(s) shall not begin until it has been 
determined that proper control procedures have been established.