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Bmr preperation
1. Facilitators: -
Dr. Vishal Kumar Gupta,
Asst Professor,
Dept. of Pharmaceutics,
JSS college of pharmacy,
Mysore.
Submitted by: -
Ram Mohan S.R.
1st M.Pharm
Pharmaceutical Quality Assurance
JSS college of pharmacy
Mysore
1
2. Batch manufacturing records should be prepared for
each intermediate and API/formulation and should
include complete information relating to the
manufacturing and control of each batch.
The batch manufacturing record should be checked
before issuance to assure that it is the correct version
and a legible accurate reproduction of the appropriate
master production instruction.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 2
3. Before any processing begins, a check should be
performed and recorded to ensure that the equipment
and workstation are clear of previous products,
documents, or materials not required for the planned
process and that the equipment is clean and suitable
for use.
These records should be numbered with a unique
batch or identification number and dated and signed
when issued.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 3
Contd……
4. The “Batch Manufacturing Record” is the
necessary quality and GMP documentation for
tracing the complete cycle of manufacturing
batch or lot
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Pharmaceutical Quality Assurance, Dept of Pharmaceutics
5. Documentation of completion of each
significant step in the BMR should include:
• Dates and, when appropriate, times
• Identity of major equipment used (e.g., reactors,
driers, mills, etc.)
• Actual results recorded for critical process
parameters
• Any sampling performed
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 5
6. • Specific identification of each batch, including weights,
measures, and batch numbers of raw materials,
intermediates, or any reprocessed materials used during
manufacturing
• Signatures of the persons performing and directly
supervising or checking each critical step in the
operation
• In-process and laboratory test results
• Actual yield at appropriate phases or times
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 6
7. • Description of packaging and label
• Representative label (commercial supply)
• Any deviation noted, its evaluation, and investigation
conducted (if appropriate) or reference to that
investigation (if stored separately).
• A decision for the release or rejection of the batch, with
the date and signature of the person responsible for the
decision.
• Results of release testing
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 7
8. • Production and quality control records should be
reviewed as part of the approval process of batch
release.
• Any divergence or failure of a batch to meet its
specifications should be thoroughly investigated.
• The investigation should, if necessary, extend to
other batches of the same product and other products
that may have been associated with the specific
failure or discrepancy.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 8
10. Issue of batch manufacturing record
( by Quality Assurance)
1) Based on Production planning, production manager
shall decide on the product and the number of batches
to be produced in the month.
2) Production supervisor shall raise the requisition for the
batches to be taken for the week and forward it to
Quality Assurance.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 10
11. 3) On receipt of Batch Manufacturing Record issue
requisition QA personnel will verify the details
entered in the requisition form.
4) A photocopy of the MASTER COPY of the
required Product Batch Manufacturing Record
will be taken.
5) All the pages of the photocopied sheet of Product
Batch Manufacturing Record shall be signed and
dated by QA Personnel.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 11
12. 6) Check for the correctness of the Batch number by
verifying the BMR register.
7) Enter the details of Date, Product, Batch No, Batch
size, Manufacturing Date, Expiry Date and issued
by details in the BMR register.
8) Check and allot expiry date by referring to master
list of product shelf life.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 12
13. 9) Enter the batch no. On all the pages of the BMR and get
it authorized by QA manager or in absence by QA
executive or QA officer.
10) Insert the signed batch record in a BMR cover and enter
the details of product name, batch number, batch size.
Manufacturing date and expiry date.
11) Batch record along with the batch record register shall be
sent to production, the production person receiving the
batch record should sign on the batch record register to
acknowledge the receipt of batch record.
12) QA person who has issued Batch Record shall sign the
“issued by” on batch record issue requisition sheet and file the
same for future reference.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 13
14. Entry of Batch Manufacturing Records
(By Production Personnel)
1) On receipt of BMR Production Manager/Dy.
production Manager shall check the BMR and sign on
the first page.
2) The calculation sheet should be forwarded to stores for
entry of the relevant AR Nos., quantity and assay
value.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 14
15. 3) After the relevant entry store forward the sheet to
production department where production chemist
fill equipment status detail where line clearance
status and ECR No. should be entered for each
equipment.
4) Now operator fill the next form of process to be
carried out for particular reactor in which starting
and ending time should be entered and finally sign
by operator and checked by in-charge.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 15
16. 5) After completion of every reaction in each of the
particular reactor intermediate should be send to QC
Lab. for checking of completion of reaction, LOD etc.
6) After final product obtained send the request to QC
for complete analysis of the product and send the
analytical report.
7) Fill all remaining entry and attach all analytical report.
8) BMR should be then send to QA department for
Review
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 16
17. Review and Control of Batch Manufacturing
Records
( by Quality Assurance)
1) Batch No. should be checked by Quality assurance
department.
2) Review the Analytical report of all raw materials
attached with BMR and check the A.R. No.
3) Review the Equipment Cleaning Record for each
equipment and relevance of line clearance by QC.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 17
18. 4) Review the deviation in process which is
predefined.
5) If any deviation present change deviation report of
process should be there. Review the report of
change in deviation and its significance in the
process.
6) Check the quantity of solvent recovered in the
process. Recovery should be proper and complete.
7) Wet material packing record should be reviewed.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 18
19. 8) Drying record as well as dry material packing record
should be checked and reviewed.
9) Check the analytical report of finished product
generated by QC department.
10) Finally attach the review report with specific
number given by QA department duly dated and
singed by QA manager.
11) If everything is fine then pass the batch and allow it
for dispatch
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 19
20. 12) Send this record in safe custody of Quality
Assurance department.
13) If anybody needs the copy of BMR it should be
given as a control copy with permission of QA
Manager.
14) Every BMR should be saved for five years from
manufacturing and after that it should be destroyed
as per SOP.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 20
22. Following attachments required to be attached to Batch
Manufacturing Record before submitting the completed
BMR to Quality Assurance.
• Equipment clean record status label.
• Equipment clean record.
• Raw materials dispensed weighing slip.
• Intermediate raw material sealed.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 22
23. • Transfer note for finished goods to F.G. store.
• Raw material issue order (P.R).
• IPQC- In Process Test Request Cum Report.
• Excess material requisition (S.R.).
• Deviation note if any.
• Certificate Of Analysis (COA).
• Finish product dispatch data.
Pharmaceutical Quality Assurance, Dept of Pharmaceutics 23
