The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.

1. BMR & MFR
Dr. K. VENKATESWARA RAJU
SHRI VISHNU COLLEGE OF PHARMACY
mail4venkey@gmail.com

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BATCH RECORD REVIEW
 Batch manufacturing records should be prepared for each intermediate and API formulation and should
include complete information relations to the manufacturing and control of each batch.
 The batch manufacturing record is the necessary quality and GMP documentation for tracing the
complete cycle of manufacturing batch or lot
 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. This is called line clearance.
 Line clearance is ensuring that remnants of previous products batch have been completely removed
before starting the next product batch. It includes
 Removal of previous labels.
 Removal of previous empty containers.
 Removal of rubber stamps.
 Removal of pre-printed packaging material.
 Removal of rejects.
 Removal of unused containers, closure system.
 Removal of previous batch records.
 Cleaning of equipment of all parts of residues
 Cleaning of dustbins and any residue in them.
 If there is product changeover pre-filters in AHU are cleaned, return filters cleaned, uniforms changed.

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BATCH MANUFACTURING RECORD
 The “Batch Manufacturing Record” is the necessary quality and GMP documentation for tracing the complete cycle of
manufacturing batch or lot.
 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.
 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.
CONTENTS
 Name of the product:
 Strength
 MFR no: master formula record
 BMR no.:
 Signed & issued by QA
 Signed for completion by production
 BOM: ARNO: analytical report no. Written &signed by storesproductionwarehouse
 Bill of materials. It is a list of all raw material ingredients that are required involving more materials which do not appear in
the final product. ex: water not there-dried-IPA-after coating removed.
 ARNO: each RM&PM after it is approved is given an ARNO that gives the entire traceability for material. warehouse wt
production wt QA ensure both right.

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BATCH MANUFACTURING RECORD
Documentation of completion of each significant step in the BMR should include:
1. Dates and, when appropriate, times
2. Identity of major equipment used (e.g., reactors, driers, mills, etc.)
3. Actual results recorded for critical process parameters
4. Any sampling performed
5. Specific identification of each batch, including weights, measures, and batch numbers of raw materials, intermediates, or
any reprocessed materials used during manufacturing
6. Signatures of the persons performing and directly supervising or checking each critical step in the operation
7. In-process and laboratory test results
8. Actual yield at appropriate phases or times
9. Description of packaging and label
10. Representative label (commercial supply)
11. Any deviation noted, its evaluation, and investigation conducted or reference to that investigation
12. A decision for the release or rejection of the batch, with the date and signature of the person responsible for
the decision.
13. Results of release testing
14. Production and quality control records should be reviewed as part of approval process of batch release.
15. Any divergence or failure of a batch to meet its specifications should be thoroughly investigated.
16. 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.

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BATCH MANUFACTURING RECORD
ISSUE, ENTRY, REVIEW and CONTROL OF BMR’S
 Responsibility: -
 Primary: Officer–QA / Officer–QC/ Officer-Production
 Secondary: Manager-QA/ Manager- QC/ Manager- Production

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BATCH MANUFACTURING RECORD
 BATCH MANUFACTURING RECORD ATTACHMENTS
 Responsibility:
 Primary: Production Chemist.
 Secondary: Production Officer.
 FOLLOWING ATTACHMENTS REQUIRED TO BE ATTACHED TO BMR 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.
 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.

7. Regulatory aspects
7
Master formula records
A Master Formula Record should be available for each product, batch
and pack size

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CONTENTS OF MASTER FORMULA RECORDS
1. Name of the product together with product reference code relating to specifications.
2. Description of dosage form, strength, composition of product and batch size.
3. Patent, proprietary name of the product along with generic name of product and its ingredients and excipients
need.
4. Special mention of the substance that may disappear during the manufacturing process.
5. Specifications and reference code of each and every ingredient need in the manufacturing procedure.
6. Location and machinery need in process and their specifications including cleaning, assembling, calibrating,
sterilizing, operating procedure etc.
7. Stepwise detailed process instructions and time taken by each and every step.
8. Instructions related to in-process control i.e, quality checks, samples taken, tests to be conducted etc.
9. Requirements for storage and processing conditions of the product including containers, labelling and special
storage if any.
10. A statement regarding expected relevant intermediate and final yield within acceptable limits.
11. Packaging material details i.e, labels, boxes, foil bottles etc.
12. Any special precautions & instructions if any.
In the case of a specific formulation with various dose sizes. Ex: LVP’S of 100ml, 200ml, 300ml, 400ml, those should
be a separate MFR for each case.
For different dosage forms like blister and strip of the same drug formulation those should be separate MFR suffice
for high cost API separate MFR for high cost API separate MFR for each batch.

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Master formula records
Packaging details
There have to be authorized packaging instructions. They should have:
1. Name
2. Description of dosage form
3. Pack sizes – Number, Dose, Volume,
4. A total list of all packaging materials required for a standard batch size with
reference to the specifications of the packaging material
5. Specimens of all packaging materials
6. Line clearance instructions
7. Description of packaging operations
8. In-process controls
9. Reconciliation of materials, used, yield obtained, wastages and destroyed
10. Scope for investigation of any undue discrepancies