[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: 21CFR225.102]

[Page 168-169]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 225_CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS--Table of Contents
 
                      Subpart E_Records and Reports
 
Sec.  225.102  Master record file and production records.


    (a) The Master Record File provides the complete procedure for 
manufacturing a specific product, setting forth the formulation, 
theoretical yield, manufacturing procedures, assay requirements, and 
labeling of batches or production runs. The production record(s) 
includes the complete history of a batch or production run. This record 
includes the amounts of drugs used, the amount of medicated feed 
manufactured, and provides a check for the daily inventory record of 
drug components.
    (b) The Master Record File and production records shall comply with 
the following provisions:
    (1) A Master Record File shall be prepared, checked, dated, and 
signed or initialed by a qualified person and shall be retained for not 
less than 1 year after production of the last batch or production run of 
medicated feed to which it pertains. The Master Record File or card 
shall include at least the following:
    (i) The name of the medicated feed.
    (ii) The name and weight percentage or measure of each drug or drug 
combination and each nondrug ingredient to be used in manufacturing a 
stated weight of the medicated feed.
    (iii) A copy or description of the label or labeling that will 
accompany the medicated feed.
    (iv) Manufacturing instructions or reference thereto that have been 
determined to yield a properly mixed medicated feed of the specified 
formula for each medicated feed produced on a batch or continuous 
operation basis, including mixing steps, mixing times and, in the case 
of medicated feeds produced by continuous production run, any additional 
manufacturing directions including, when indicated, the settings of 
equipment.
    (v) Appropriate control directions or reference thereto, including 
the manner and frequency of collecting the required number of samples 
for specified laboratory assay.
    (2) The original production record or copy thereof shall be prepared 
by qualified personnel for each batch or run of medicated feed produced 
and shall be retained on the premises for not less than 1 year. The 
production record shall include at least the following:
    (i) Product identification, date of production, and a written 
endorsement in the form of a signature or initials by a responsible 
individual.
    (ii) The quantity and name of drug components used.
    (iii) The theoretical quantity of medicated feed to be produced.
    (iv) The actual quantity of medicated feed produced. In those 
instances where the finished feed is stored in bulk and actual yield 
cannot be accurately determined, the firm shall estimate the quantity 
produced and provide the basis for such estimate in the Master Record 
File.
    (3) In the case of a custom formula feed made to the specifications 
of a customer, the Master Record File and production records required by 
this section shall consist either of such records or of copies of the 
customer's purchase orders and the manufacturer's invoices bearing the 
information required by this section. When a custom order is received by 
telephone, the manufacturer shall prepare the required production 
records.
    (4) Batch production records shall be checked by a responsible 
individual at the end of the working day in which the product was 
manufactured to determine whether all required production steps have 
been performed. If significant discrepancies are noted, an investigation 
shall be instituted immediately, and the production record shall 
describe the corrective action taken.
    (5) Each batch or production run of medicated feed shall be 
identified with its own individual batch or production

[[Page 169]]

run number, code, date, or other suitable identification applied to the 
label, package, invoice or shipping document. This identification shall 
permit the tracing of the complete and accurate manufacturing history of 
the product by the manufacturer.