Allow me a few minutes to "fine tune" Michael's comments.
I've attached 21 CFR § 211.186 "Master production and control records" and §
211.188 "Batch production and control records" below so that you can review
the FDA requirements verbatim.
Many organizations refer to the photocopy of the Master Production and
Control Record (MPCR) as the "batch record" even though this is strictly not
the case. While the Batch Production and Control Record (BPCR) does include
a photocopy of the MPCR, it also includes many other things, such as
laboratory results, line clearing reports, equipment cleaning logs /
reports, labeling info, etc.
If you are attempting to streamline your batch record workflow, and
particularly if your trying to rigorously model and / or automate it, you
will quickly encounter the paradox of calling everything the "batch record."
(E.g. From a data entity / data modeling standpoint, how do you discriminate
between the raw photocopy, the lot-numbered photocopy, the photocopy
inscribed with data, and the manila folder holding the photocopy and all of
the other items?)
We have found it useful to use the term "Dispatch Production and Control
Record" (DPCR or "dispatch record") to refer to the lot-numbered, specific
photocopy of the MPCR that will become a part of the BPCR. In workflow
modeling terms, the DPCR is an output of the Scheduling process, a data
element of the Production process, and a "child" data element of the
I hope you find this useful.
Thomas Quinn, CISSP, AAA
President, The Hollis Group, Inc.
v: 610-889-7350 f: 610-296-2339
"The most expensive way to do anything is twice." (tm)
(This message is copyrighted ©2004, The Hollis Group, Inc.)
§ 211.186 Master production and control records.
(a) To assure uniformity from batch to batch, master production and control
records for each drug product, including each batch size thereof, shall be
prepared, dated, and signed (full signature, handwritten) by one person and
independently checked, dated, and signed by a second person. The preparation
of master production and control records shall be described in a written
procedure and such written procedure shall be followed.
(b) Master production and control records shall include:
(1) The name and strength of the product and a description of the dosage
(2) The name and weight or measure of each active ingredient per dosage unit
or per unit of weight or measure of the drug product, and a statement of the
total weight or measure of any dosage unit;
(3) A complete list of components designated by names or codes sufficiently
specific to indicate any special quality characteristic;
(4) An accurate statement of the weight or measure of each component, using
the same weight system (metric, avoirdupois, or apothecary) for each
component. Reasonable variations may be permitted, however, in the amount of
components necessary for the preparation in the dosage form, provided they
are justified in the master production and control records;
(5) A statement concerning any calculated excess of component;
(6) A statement of theoretical weight or measure at appropriate phases of
(7) A statement of theoretical yield, including the maximum and minimum
percentages of theoretical yield beyond which investigation according to §
211.192 is required;
(8) A description of the drug product containers, closures, and packaging
materials, including a specimen or copy of each label and all other labeling
signed and dated by the person or persons responsible for approval of such
(9) Complete manufacturing and control instructions, sampling and testing
procedures, specifications, special notations, and precautions to be
§ 211.188 Batch production and control records.
Batch production and control records shall be prepared for each batch of
drug product produced and shall include complete information relating to the
production and control of each batch. These records shall include:
(a) An accurate reproduction of the appropriate master production or control
record, checked for accuracy, dated, and signed;
(b) Documentation that each significant step in the manufacture, processing,
packing, or holding of the batch was accomplished, including:
(2) Identity of individual major equipment and lines used;
(3) Specific identification of each batch of component or in-process
(4) Weights and measures of components used in the course of processing;
(5) In-process and laboratory control results;
(6) Inspection of the packaging and labeling area before and after use;
(7) A statement of the actual yield and a statement of the percentage of
theoretical yield at appropriate phases of processing;
(8) Complete labeling control records, including specimens or copies of all
(9) Description of drug product containers and closures;
(10) Any sampling performed;
(11) Identification of the persons performing and directly supervising or
checking each significant step in the operation;
(12) Any investigation made according to § 211.192.
(13) Results of examinations made in accordance with § 211.134.