Standard Operating Procedure for Documenting Dispensing Activities in BMR

Department	Capsule Manufacturing
SOP No.	SOP/CM/011/2025
Supersedes	SOP/CM/011/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

To establish the procedure for documenting dispensing activities in the Batch Manufacturing Record (BMR) to ensure traceability, accountability, and compliance with regulatory requirements.

2. Scope

This SOP applies to all dispensing activities performed in capsule manufacturing, specifically focusing on the documentation of activities within the BMR for traceability and quality control.

3. Responsibilities

• Manufacturing Personnel: Responsible for documenting all dispensing activities accurately in the BMR as per the work order and batch record requirements.
• Quality Control (QC) Team: Ensures the documentation in the BMR is complete, accurate, and in compliance with quality standards.
• Quality Assurance (QA) Team: Oversees the BMR documentation process and ensures that all dispensing activities are appropriately recorded and verified.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring that dispensing activities are properly documented. The QA Manager is responsible for verifying the accuracy and completeness of BMR documentation.

5. Procedure

5.1 Documenting Dispensing Activities

Follow these steps to document dispensing activities in the BMR:

1. Verify Work Order
   1. Ensure that the correct work order and batch record are available for the dispensing process.
   2. Check the material specifications, quantities, and batch numbers listed in the work order against the materials to be dispensed.
2. Record Dispensing Information
   1. Document the material name, batch number, quantity dispensed, and the date of dispensing in the BMR.
   2. Include the names and signatures of personnel involved in the dispensing activity (e.g., dispensers, QA personnel).
3. Confirm Material Identity
   1. Verify that the materials being dispensed match the descriptions provided in the work order and BMR.
   2. Ensure that the correct material is being dispensed and that it meets the required specifications (e.g., weight, type, batch number).
4. Verify Dispensing Quantity
   1. Check the quantity of the material to be dispensed against the quantity stated in the work order and batch record.
   2. Ensure that any discrepancies are documented and corrective actions are taken if necessary.
5. Cross-Check Dispensing Details
   1. After dispensing, cross-check the documentation for accuracy and ensure it aligns with the physical dispensed quantities and materials.
   2. Verify that all fields in the BMR are filled out, including the batch number, material identification, and personnel signatures.

5.2 Review and Verification

Once the dispensing activity is documented, the following verification steps should be performed:

1. QA Review
   1. QA personnel should review the BMR to ensure all dispensing activities are documented accurately and completely.
   2. Verify that all required information (e.g., material names, batch numbers, quantities) is present and consistent with the work order and batch record.
2. Discrepancy Resolution
   1. If discrepancies are found, document them in the Discrepancy Report (Annexure-1) and initiate corrective actions.
   2. Ensure that any corrections made to the BMR are documented with appropriate explanations and signed by the responsible personnel.

5.3 Final Approval

After the dispensing activities are documented and verified, the BMR should be signed and approved:

1. Signature and Approval
   1. Once all documentation is complete and verified, obtain the signatures of the Manufacturing Supervisor and QA personnel.
   2. Ensure that the BMR is filed appropriately for future reference and regulatory compliance.
2. Record Retention
   1. Store the completed BMR in a secure location as per the company’s record retention policy and regulatory guidelines.
   2. Ensure that the BMR is readily accessible for audits or inspections.

5.4 Documentation and Record-Keeping

Ensure all relevant records are maintained and easily accessible for regulatory compliance:

1. Batch Manufacturing Record
   1. Ensure the BMR is filled out accurately and completely, including all dispensing details, work order information, and personnel signatures.
   2. Verify that any changes or corrections to the BMR are documented according to company policy and approved by the appropriate personnel.
2. Discrepancy Report
   1. Document any discrepancies found during the dispensing process in the Discrepancy Report (Annexure-1) and follow up with corrective actions as necessary.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Manufacturing Record (BMR) (Annexure-2)
2. Discrepancy Report (Annexure-1)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Discrepancy Report

Date	Material Name	Batch Number	Issue Description	Corrective Action
03/02/2025	API-123	Batch 67890	Dispensing quantity mismatch	Reweighed and verified material quantity

Annexure-2: Batch Manufacturing Record (BMR)

Date	Material Name	Batch Number	Quantity Dispensed	Dispensed By
03/02/2025	Excipient-456	Batch 12345	500 g	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated documentation requirements	Standardization	QA Head