[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: 21CFR226.102]

[Page 174-175]
 
                        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 E_Records and Reports
 
Sec.  226.102  Master-formula and batch-production records.


    (a) For each Type A medicated article(s) master-formula records 
shall be prepared, endorsed, and dated by a competent and responsible 
individual and shall be independently checked, reconciled, endorsed, and 
dated by a second competent and responsible individual. The record shall 
include:
    (1) The name of the Type A medicated article(s) and a specimen copy 
of its label.
    (2) The weight or measure of each ingredient, adequately identified, 
to be used in manufacturing a stated weight of the Type A medicated 
article(s).
    (3) A complete formula for each batch size, or of appropriate size 
in the case of continuous systems to be produced from the master-formula 
record, including a complete list of ingredients designated by names or 
codes sufficiently specific to indicate any special quality 
characteristics; an accurate statement of the weight or measure of each 
ingredient, except that reasonable variations may be permitted in the 
amount of ingredients necessary in the preparation of the Type A 
medicated article(s), provided that the variations are stated in the 
master formula; an appropriate statement concerning any calculated 
excess of an ingredient; and a statement of the theoretical yield.
    (4) Manufacturing instructions for each type of Type A medicated 
article(s) produced on a batch or continuous operation basis, including 
mixing steps and mixing times that have been determined to yield an 
adequately mixed Type A medicated article(s); and in the case of Type A 
medicated article(s) produced by continuous production run, any 
additional manufacturing directions including, when indicated, the 
settings of equipment that have been determined to yield an adequately 
mixed Type A medicated article(s) of the specified formula.
    (5) Control instructions, procedures, specifications, special 
notations, and precautions to be followed.
    (b) A separate batch-production and control record shall be prepared 
for each batch or run of Type A medicated article(s) produced and shall 
be retained for at least 2 years after distribution by the manufacturer 
has been completed. The batch-production and control record shall 
include:
    (1) Product identification, date of production, and endorsement by a 
competent and responsible individual.
    (2) Records of each step in the manufacturing, packaging, labeling, 
and controlling of the batch, including dates, specific identification 
of drug components used, weights or measures

[[Page 175]]

of all components, laboratory-control results, mixing times, and the 
endorsements of the individual actively performing or the individual 
actively supervising or checking each step in the operation.
    (3) A batch number that permits determination of all laboratory-
control procedures and results on the batch and all lot or control 
numbers appearing on the labels of the Type A medicated article(s).