This document discusses batch manufacturing records (BMRs), which are necessary quality and GMP documentation used to trace the complete manufacturing cycle of a batch or lot of a product. A BMR contains information about the batch including the batch number, size, composition, manufacturing record, weight of drug, shelf life, and storage conditions. It also includes general manufacturing instructions, a cleaning record of equipment used, a bill of materials listing raw materials, step-by-step manufacturing process details, yield calculations, a list of abbreviations, and a history of changes made to the document. A good BMR format contains all of this essential information.

1. BATCH MANUFACTURING
RECORD
NAME- CHANDA MALVIYA
BANSAL COLLEGE OF
PHARMACY

2. RECORD

3. INTRODUCTIO
N
1. What is document
2. Type of document

4. What is
document
 Document is a paper that provide information
especially of an official or legal nature ,written
report or record.
 Documentation: It is a method of preparing
written material which describe the process in
terms of specification instruction.

5. Type of documentation
Major two types :
1. BATCH FORMULA RECORD
2. MASTER FORMULA RECORD

6. BATCH MANUFACTURING
RECORD
 The batch manufacturing record [BMR] is the
necessary quality and GMP documentation for
tracing the complete cycle of manufacturing of a
batch or lot.
 BMR may be prepared in local language.
 BMR is a written document from the batch that is
prepared during the p’ceutical manufacturing
process.
 A good BMR format should contain following
part:
1. Batch record: First page of the BMR has all
records about the batch as batch no. ,batch size
,composition MFR, wt of drug shelf life, storage
condition ,mfg date ,expiry date date of starting

7. Conti…
2. General instruction for mfg: Health and safety
instruction to the operation and be followed
during the mfg process regarding the material
and equipment used during mfg.
3. Equipment cleaning record: Check list of the
cleaning of all equipment is prepared. Those are
used in the mfg of the batch including the
previous product batch and date of cleaning.
4. Bills of materials: list of the raw materials should
have the quantity of the material with that AR
number. Weight of the material should be verified
by QA.

8. Conti…
5. Mfg process: should be written step by step in
easy language.
Milling ,sifting drying, lubrication, compression,
coating and packing having all instruction with
process time should be written.
6. Yield: Yield of the batch should be calculated at
the end of the every stage to calculate the
process loss.Final yield should be calculated at
the end of the manufacturing that should not be
less than 99.00%.
7. Abbreviations: list of the abbreviation used in the
document should be made to understand the
BMR easily.

9. Conti…
8. History of changes: At the end the document
should have a list of the changes in the document
including the revision no. and date of change.

10. BATCH MANUFACTURING
RECORD