Standard Operating Procedure for Reconciliation of Raw Materials Post Dispensing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/015/2025 |
| Supersedes | SOP/ELX/015/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define a standardized procedure for reconciling raw materials after dispensing, ensuring accountability, traceability, and compliance with cGMP to avoid mix-ups, losses, or misappropriation of raw materials in elixir manufacturing.
2. Scope
This SOP applies to all raw materials including active ingredients, excipients, solvents, and additives dispensed for elixir production in the Elixir Department and covers reconciliation immediately following completion of the dispensing activity.
3. Responsibilities
- Dispensing Operator:
- Weigh and record quantities dispensed and remaining.
- Label leftover material containers and segregate for return or rejection.
- Warehouse Supervisor:
- Verify reconciliation data and ensure documentation accuracy.
- QA Officer:
- Cross-check reconciliation figures and approve material return or destruction.
4. Accountability
The Head of Warehouse and Head of QA are accountable for ensuring all raw materials are properly reconciled, recorded, and verified post dispensing.
5. Procedure
5.1 Completion of Dispensing Activity
- Once dispensing for a batch is complete, record the exact quantity of each material dispensed into the Batch Manufacturing Record (BMR).
- Label all partially used containers with:
- “Partially Used” tag
- Material name and code
- Remaining quantity
- Batch number
- Date
5.2 Material Reconciliation
- Compare the following parameters for each material used:
- Issued Quantity
- Quantity Dispensed
- Remaining Quantity
- Quantity Rejected (if any)
- Ensure total matches the originally issued quantity.
- Record all details in the Material Reconciliation Sheet (Annexure-1).
5.3 Verification and Approval
- Warehouse Supervisor reviews entries and physically verifies balances.
- QA performs independent verification by matching:
- Dispensed logs
- Label quantities
- BMR entries
- Sign the reconciliation sheet and approve the movement of leftover materials.
5.4 Handling Leftover Materials
- If leftover material is clean, properly labeled, and within expiry:
- Return to approved storage location under “Partially Used” status.
- If material is suspected to be contaminated, expired, or damaged:
- Segregate and label as “REJECTED.”
- Record in Rejected Material Log.
5.5 Handling Discrepancies
- In case of material shortfall or excess:
- Document deviation in the Deviation Form.
- Investigate root cause and implement corrective actions.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- cGMP: Current Good Manufacturing Practice
7. Documents
- Material Reconciliation Sheet (Annexure-1)
- Rejected Material Log (if applicable)
- Deviation Report (if applicable)
8. References
- 21 CFR Part 211 – Subpart E: Control of Components
- WHO GMP – Materials Management and Reconciliation
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Material Reconciliation Sheet
| Material Name | Batch No. | Issued Qty (kg) | Dispensed Qty (kg) | Returned Qty (kg) | Rejected Qty (kg) | Remarks |
|---|---|---|---|---|---|---|
| Sorbitol | SB0425A | 25 | 23 | 2 | 0 | Reconciled |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial Version | New SOP | QA Head |
| 13/04/2025 | 2.0 | Included deviation and discrepancy handling section | Audit Observation | QA Head |