Standard Operating Procedure for Recording Dispensed Quantities in Batch Manufacturing Record (BMR)
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/043/2025 |
| Supersedes | SOP/ELX/043/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for accurately recording dispensed material quantities in the Batch Manufacturing Record (BMR) in the Elixir Department, ensuring traceability, compliance with cGMP, and documentation integrity.
2. Scope
This SOP applies to all materials dispensed for use in elixir formulations including active ingredients, excipients, solvents, and preservatives. It is applicable to production and quality assurance personnel involved in BMR documentation.
3. Responsibilities
- Dispensing Operator:
- Enter the actual dispensed quantities into the BMR as per batch requirements.
- Supervisor:
- Verify and countersign the recorded entries for accuracy and completeness.
- QA Officer:
- Audit the entries and ensure corrections (if any) are performed as per ALCOA+ principles.
4. Accountability
The Production Head is accountable for ensuring that all dispensed quantities are accurately recorded and verified in the BMR in accordance with GMP documentation practices.
5. Procedure
5.1 Before Recording
- Ensure the correct BMR version is issued and the batch number is clearly mentioned.
- Cross-check the approved bill of materials and the actual materials dispensed against the Material Requisition Form.
5.2 Entry of Dispensed Quantities
- Record the following details in the “Material Dispensing Section” of the BMR:
- Material Name
- Material Code (if applicable)
- Batch Number of Material
- Quantity Required
- Quantity Dispensed
- Container Number(s)
- Date and Time of Dispensing
- Signature of Dispensing Operator
- Enter values in legible handwriting using a blue or black permanent pen.
- Do not overwrite; for corrections, strike a single line, write the correct value, and initial with date/time.
5.3 Review and Verification
- The Supervisor shall:
- Verify that the actual quantity matches with batch requirement within allowable limits.
- Ensure no unauthorized correction or tampering is observed.
- Sign and date the verification section.
- QA shall:
- Randomly check selected entries and ensure they match with the Dispensing Logbook and labels.
- Initial and date the reviewed pages in the BMR.
5.4 Reconciliation Entry
- Record the reconciliation at the end of the dispensing table:
- Total Quantity Required
- Total Quantity Dispensed
- Excess/Shortage (if any) with reason
- Sign and verify the reconciliation data with QA authorization.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
7. Documents
- Batch Manufacturing Record (Annexure-1)
- Material Dispensing Log (Annexure-2)
- Verification and Reconciliation Sheet (Annexure-3)
8. References
- 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals
- WHO TRS 996 Annex 5 – GMP for Documentation
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Manufacturing Record – Material Entry Section
| Material | Code | Batch No. | Required Qty | Dispensed Qty | Container No. | Dispensed By | Date |
|---|---|---|---|---|---|---|---|
| Sodium Citrate | SC001 | SC2288 | 5.0 kg | 5.0 kg | 1 of 1 | Rajesh Kumar | 11/04/2025 |
Annexure-2: Material Dispensing Log
| Date | Material | Batch No. | Qty | Dispensed By | Verified By |
|---|---|---|---|---|---|
| 11/04/2025 | Sodium Citrate | SC2288 | 5.0 kg | Rajesh Kumar | Sunita Reddy |
Annexure-3: Verification and Reconciliation Sheet
| Material | Required Qty | Dispensed Qty | Reconciled | Verified By |
|---|---|---|---|---|
| Sodium Citrate | 5.0 kg | 5.0 kg | Yes | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | Document Creation | QA Head |
| 11/04/2025 | 2.0 | Annexures and ALCOA+ Compliance Added | Audit & Documentation Standardization | QA Head |