BMR (Batch Manufacturing Record)

1. 1. 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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. 
2. 2. 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 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. Contd……
3. 3. The “Batch Manufacturing Record” is the necessary quality and GMP documentation for tracing the
complete cycle of manufacturing batch or lot 4 Pharmaceutical Quality Assurance, Dept of
Pharmaceutics
4. 4. 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
5. 5. • 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
6. 6. • 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
7. 7. • 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
8. 8. Responsibility :- Primary: Officer–QA / Officer–QC/ Officer-Production Secondary: Manager-QA/
Manager- QC/ Manager- Production Pharmaceutical Quality Assurance, Dept of Pharmaceutics 9
9. 9. 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
10. 10. 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
11. 11. 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
12. 12. 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
13. 13. 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
14. 14. 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
15. 15. 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
16. 16. 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
17. 17. 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
18. 18. 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
19. 19. 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
20. 20. Batch Manufacturing Record Attachments Responsibility : Primary : Production Chemist.
Secondary : Production Officer. Pharmaceutical Quality Assurance, Dept of Pharmaceutics 21
21. 21. 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
22. 22. • 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