A batch Manufacturing Record (BMR) is a document that contains all the necessary information related to the manufacturing process of a specific batch of a product. The SOP for Preparation of Batch Manufacturing Record (BMR) is a critical document that provides a comprehensive and detailed account of the manufacturing process and is used to ensure that the batch is manufactured in accordance with established procedures and specifications. Overall, the BMR should be a complete and accurate record of the manufacturing process for a specific batch of a product. It should provide all the information necessary to ensure that the batch is manufactured in accordance with established procedures and meets the required quality standards.

PURPOSE

The purpose of this SOP is to set forth the procedure for the compilation of BMR as per GMP requirements.

SCOPE

This SOP is applicable to all product batches manufactured and packed in Pharmaceuticals.

DEFINITIONS

Batch

A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.

Batch No

A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.

Manufacture

All operations of purchase of materials and products, production, quality control (QC), release, storage and distribution of pharmaceutical products, and the related controls.

Batch Record

All documents associated with the manufacture of a batch of bulk product or finished product. They SOP for Preparation of Batch Manufacturing Record (BMR) provide a history of each batch of product and of all circumstances pertinent to the quality of the final product

In-process control

Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.

Finished Product

A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labeling.

ABBREVIATIONS

• BMR Batch Manufacturing Record
• FG Finished Goods
• MP Manufacturing Procedure
• QC Quality Control
• QA Quality Assurance
• Batch No. Batch Number
• AM Assistant Manager
• AM P&IC Assistant Manager Planning and Inventory Control
• PWO Packaging Work Order
• CQF Company Quality Form
• PQF Production Quality Form
• QAF Quality Assurance Form
• MF Master Formulation
• GMP Good Manufacturing Practices
• R&D Research and development

RESPONSIBILITIES

AM P&IC

1. Receive production plan from Production Manager.
2. Allot Batch Number, Manufacturing and Expiry Date to Batch from Batch Register
3. Compile BMR file containing Manufacturing Procedure, Raw Material Move Order and Packaging Work Order
4. Issuance of Raw and Packaging Materials to Production after getting approval from QA.
5. Assure storage conditions for dispensed batch.
6. Transfer of the Released Batch(Finished Product)from Production to Transit warehouse.

AM Quality Assurance

1. Approval of Raw Material Mover Order and Packaging Move order as per Master Formulation.

Quality Assurance Officer

1. Line Clearance before the start of all steps of manufacturing and packing Operations
2. Sampling of all in-process and finished product stages (where required)
3. In-process Monitoring and documentation
4. Perform in-process control tests on in-process control sheet.
5. Review of BMR after completion of each step.

Production Officer

1. Document all manufacturing and packaging operations details in BMR.
2. Fill line clearance check sheet and get approval from QA before the start of all Manufacturing and Packaging operations.
3. Get Quality reports and Releases from QC (where applicable) before proceeding to next step
4. Perform in-process control tests and document on in-process control Sheets.
5. Document batch reconciliation at the end of each manufacturing step and Final batch reconciliation
6. Document all the personnel deputed for activity on team lay out sheet
7. Initiate deviation and CAPA form (if required) and get approval.

Quality Control Officer

1. Preparation of Quality Reports and Released slips
2. Initiate OOS. (If required)

Quality Assurance Manager

1. Release of finished product for dispatch
2. Retain the BMR till one year after the expiry of product.
3. Destroy the BMR after retention period.

Production Manager

1. Review of BMR for completeness and authenticity before release of finished Product

PROCEDURE

Raw Material and Packing Move Orders

1. Assistant Manager P & IC shall receive production plan from Production Manager.
2. Assistant Manager P & IC shall allot batch No. Manufacturing and expiry dates to a particular batch of product from batch register.
3. Assistant Manager P & IC shall generate raw material move order and Packaging move order of a batch against Batch No, Mfg and Expiry dates that has been allotted from Batch Register.
4. Assistant Manager P & IC shall made potency adjustment of API with requisite filler on potency weight adjustment sheet(a part of Raw Material Move order) according to.
5. Assistant Manager P & IC shall compile BMR file of a product containing prints of raw material move order along with potency weight adjustment sheet, Manufacturing Procedure, Packing procedure and Packaging move order.
6. Assistant Manager P & IC shall write Registration No. of the product and Quality Control No of each Raw and packaging material on Raw Material and Packaging move orders respectively.
7. Assistant Manager P & IC shall send this BMR file to Assistant Manager QA for approval.
8. Assistant Manager QA shall approve the Raw material and Packaging move orders for dispensing after verification of formulation, calculation and other particulars of product. (Registration no, pack size, Manufacturing and Expiry dates etc)
9. Assistant Manager QA will send back the BMR file to Assistant Manger P & IC after approval for dispensing operation.
10. Dispensing officer shall fulfill the requirements for dispensing and get line clearance for dispensing from QA Officer.
11. Dispensing officer and QA officer shall check and countercheck the dispensing operation respectively (weight/quantity of ingredients, QC no of ingredients and %age of API) from approved move order and QC release pasted on drum/container from which material is going to be dispensed for batch.
12. Dispensing officer shall fill the Packaging/Raw material identification card and will tag it with dispensed material as soon as material is dispensed.
13. Dispensing officer and QA officer shall sign the relevant field on move orders and Dispensing officer shall issue the Raw and Packaging materials of the batch to production officer.
14. Production officer shall check the weight/quantity of ingredients, QC no. of ingredients from Approved move orders and Packaging/Raw material identification card and shall receive the dispensed material after signing the relevant field on move orders and Packaging/ Raw material identification cards.
15. Dispensing officer shall handover the dispensed batch and BMR containing Index sheet line clearance check sheet and card for dispensing, Manufacturing and packing procedure and approved and completed move orders to concerned production officer.

Manufacturing and Packing Procedure

1. Production officer shall record compliance of manufacturing and packing activities and document it at the time of execution.
2. QA officer shall ensure compliance of the manufacturing and packing activities and document it at the time of execution.
3. Production officer shall paste the Packaging/Raw material identification card of each ingredient of batch in BMR during manufacturing and packing process.
4. Production officer shall paste the release slip in manufacturing procedure at relevant field before start up of manufacturing step.
5. Production and QA officers shall complete and document the previous inprocess step in BMR before proceeding to next step.
6. Production officer shall calculate final batch yield at end of packing procedure and document in the packaging move order.
7. QA officer shall counter check the final batch yield calculation documented on packaging move order.

Line Clearance Check Sheets And Cards

1. Dispensing officer and Production officer shall fulfill the requirements of process and get line clearance from QA officer before startup of all operations.
2. Dispensing officer and Production officer shall check compliance of area/machine/ equipment; fill the “line clearance check sheet” and “Equipment ID and Status card” for getting line clearance.
3. QA officer shall assure compliance of the area/machine/equipment and give line clearance according to “line clearance check sheet” and “Equipment ID and Status Card”
4. Line clearance check sheets shall become part of BMR before startup of each dispensing, manufacturing and packaging operation and Equipment ID and Status Card shall become part of BMR at end of each dispensing, manufacturing and packaging operation.
5. Production officer and QA officer shall check and sign the first overprinted sample of secondary packaging material before startup of overprinting process.
6. Production officer shall place the overprinted sample of secondary packaging material duly signed and counter signed by production and QA officer in the BMR at back of line clearance check sheet for overprinting.
7. Production officer shall place the packaging components (blisters, literature, label, unit carton and shipper stickers etc.) duly signed and counter signed by the production and QA officer in BMR at back of line clearance check sheet for packing.

Quality Reports

1. QC officer shall provide Quality Reports of batch at intermediate and finished stage.
2. QC officer shall provide Release slips of batch at intermediate stages.
3. Production officer shall place Quality Report of relevant stage in BMR before proceeding to next inprocess step and line clearance from QA.
4. QC officer shall provide Certificate of Analysis of the batch.

Inprocess Control Sheets.

1. QA officer shall introduce Inprocess Control sheets in BMR for inprocess monitoring of different manufacturing and packaging operations.
2. QA officer and Production officer shall monitor the product at in-process stage (compression, filling, overprinting, packing etc) perform in-process control tests and document results in Inprocess Quality Control sheets alternately after specified interval of time along with initials.
3. QA officer shall document time at which specific manufacturing or packaging inprocess stage started and completed on inprocess quality control sheets.

Team Layout Sheets

1. Production officer shall introduce team lay out sheets in BMR representing all the personnel deputed for the packing activity.
2. Production officer shall document the time at which packaging operation started and completed on team layout sheet.
3. Production officer shall calculate periodical output and target output on team layout sheet.

Finished Product Transfer Note and final review

1. Production officer shall add up finished product transfer note/move order in the BMR.
2. Production officer shall document batch quantity to be released and transferred to transit warehouse on Finished Product transfer note/move order.
3. Production officer shall prepare “Request for partial release of packed portion of product” in the BMR and get approval from QA department for Release (if required).
4. Production officer shall document the quantity of packed portion on finished product transfer note/move order in case of partial release.
5. Concerned officers shall fill the BMR index sheet side by side as soon as any document becomes part of BMR.
6. Production Manager shall review and forward the completed BMR to QA officer for batch Release.

Released Cards and Batch Release

1. QA Manager shall review the completed BMR.
2. QA Manager shall prepare the release card,document the quantity of batch released (total no. of cartons and pieces), sign the card and paste on the BMR for batch/portion of batch release.
3. Transit Warehouse officer shall sign the finished product transfer note/move order and move the Released batch from production to transit warehouse.
4. After Batch Release BMR shall be forwarded to QA department for archival.

General Instructions

1. Papers of following standard quality shall be used for data recording in BMR.

• Color white
• Size A4
• Dimensions 297x210mm
• Grammage 80 g/m²

1. BMR shall be arranged in descending order according to the product process flow.
2. BMR should be filled by relevant officer in tidy manner.
3. Blank spaces should not be present in BMR, mark any irrelevant field as N.A (not applicable)
4. Cutting and overwriting should be avoided and in case of any mistake the relevant officer will cross the word with straight line in such a way that crossed word is legible then relevant officer will write the correct word with his initials.
5. Equipment ID and Status Card shall be placed at right top corner of line clearance check sheet.
6. Packaging/Raw material identification cards shall be placed at right top corner of manufacturing procedure.
7. Packaging material sample shall be placed at back of line clearance check sheet of that critical step.
8. Release card shall be placed at backside of finished product move order at the time of final batch release.

Contents of BMR

BMR will contain the following documents according to the respective product.

• BMR will be maintained in the BM Office File having the Title “Batch Manufacturing Record (BMR)”.
• BMR index sheet
• Move Order (Raw Material).
• Manufacturing procedure.
• Packaging/Raw material identification cards.
• Line Clearance Check sheets
• Product ID & Equipment Status Card
• Batch Analysis Report (Physical/ Chemical/ Microbiological).
• In-process Control Sheet of Powder for Suspension Packaging.
• In-process Control Sheet for Sterile Powder for Injection Packaging.
• In-process Control Sheet of Tablet & Capsule Packaging.
• In-process Control Sheet of Oral Liquid / Filling and Packaging.
• In-process Control Sheet of Liquid Inject able Packaging.
• In-Process Control Sheet Manufacturing of Solid Dosage Form (Powder for Suspension/Sterile Powder for Injection).
• In-Process Control Sheet Manufacturing of Oral Solid Dosage Form (Uncoated, Coated tablet & Capsule).
• In-process Control Sheet (Manufacturing of Liquid Injectable)
• In process weight monitoring sheet (Manufacturing of oral solid dosage form).
• In process weight monitoring sheet (Manufacturing of sterile powder for injection).
• Optical checking sheet (Liquid Injectable)
• Packaging work order of Product.
• Team Layout Sheet.
• Certificate of analysis.
• Deviation and CAPA.(If applicable)
• Finished Product Transfer Note/Move order.
• Release Card.
• Sample of packaging materials duly signed by production and QA officer.

REFERENCES

• WHO TRS 986, Annexure 2 par 15.25,15.26,15.27,15.28,15.29,15.30
• Quality Assurance of pharmaceuticals volume 2. (2nd updated edition)

DISTRIBUTION

• Quality Assurance
• Production
• Warehouse