[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: 21CFR226.102]

[Page 148-149]
 
                        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:

[[Page 149]]

    (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 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).