[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.260]

[Page 249-250]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
 Subpart I_Production and Process Control System: Requirements for the 
                         Batch Production Record
 
Sec.  111.260  What must the batch record include?

    The batch production record must include the following:
    (a) The batch, lot, or control number:
    (1) Of the finished batch of dietary supplement; and
    (2) That you assign in accordance with Sec.  111.415(f) for the 
following:
    (i) Each lot of packaged and labeled dietary supplement from the 
finished batch of dietary supplement;
    (ii) Each lot of dietary supplement, from the finished batch of 
dietary supplement, that you distribute to another person for packaging 
or labeling;
    (b) The identity of equipment and processing lines used in producing 
the batch;
    (c) The date and time of the maintenance, cleaning, and sanitizing 
of the equipment and processing lines used in producing the batch, or a 
cross-reference to records, such as individual equipment logs, where 
this information is retained;
    (d) The unique identifier that you assigned to each component (or, 
when applicable, to a product that you receive from a supplier for 
packaging or labeling as a dietary supplement), packaging, and label 
used;
    (e) The identity and weight or measure of each component used;
    (f) A statement of the actual yield and a statement of the 
percentage of theoretical yield at appropriate phases of processing;
    (g) The actual results obtained during any monitoring operation;
    (h) The results of any testing or examination performed during the 
batch production, or a cross-reference to such results;
    (i) Documentation that the finished dietary supplement meets 
specifications established in accordance with Sec.  111.70(e) and (g);
    (j) Documentation, at the time of performance, of the manufacture of 
the batch, including:
    (1) The date on which each step of the master manufacturing record 
was performed; and
    (2) The initials of the persons performing each step, including:
    (i) The initials of the person responsible for weighing or measuring 
each component used in the batch;
    (ii) The initials of the person responsible for verifying the weight 
or measure of each component used in the batch;
    (iii) The initials of the person responsible for adding the 
component to the batch; and
    (iv) The initials of the person responsible for verifying the 
addition of components to the batch;
    (k) Documentation, at the time of performance, of packaging and 
labeling operations, including:
    (1) The unique identifier that you assigned to packaging and labels 
used, the quantity of the packaging and labels used, and, when label 
reconciliation is required, reconciliation of any discrepancies between 
issuance and use of labels;
    (2) An actual or representative label, or a cross-reference to the 
physical location of the actual or representative label specified in the 
master manufacturing record; and
    (3) The results of any tests or examinations conducted on packaged 
and labeled dietary supplements (including repackaged or relabeled 
dietary supplements), or a cross-reference to the physical location of 
such results;
    (l) Documentation at the time of performance that quality control 
personnel:
    (1) Reviewed the batch production record, including:
    (i) Review of any monitoring operation required under subpart E of 
this part; and
    (ii) Review of the results of any tests and examinations, including 
tests and examinations conducted on components, in-process materials, 
finished batches of dietary supplements, and packaged and labeled 
dietary supplements;
    (2) Approved or rejected any reprocessing or repackaging; and
    (3) Approved and released, or rejected, the batch for distribution, 
including any reprocessed batch; and

[[Page 250]]

    (4) Approved and released, or rejected, the packaged and labeled 
dietary supplement, including any repackaged or relabeled dietary 
supplement.
    (m) Documentation at the time of performance of any required 
material review and disposition decision.
    (n) Documentation at the time of performance of any reprocessing.