Standard Operating Procedure for Reconciliation of Packaging Materials Post-Production
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/246/2025 |
| Supersedes | SOP/TAB/246/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/07/2026 |
| Effective Date | 06/07/2026 |
| Review Date | 01/07/2027 |
1. Purpose
The purpose of this SOP is to provide a systematic approach for reconciling packaging materials used during production. This ensures that the usage of packaging materials aligns with the production plan, preventing overuse, wastage, or discrepancies. Proper reconciliation contributes to inventory control, cost management, and adherence to GMP standards.
2. Scope
This SOP applies to all packaging materials used in tablet production, including primary and secondary packaging materials. It covers the reconciliation process that occurs post-production, once the production batch is completed and ready for packaging.
3. Responsibilities
- Packaging Operators: Responsible for accurately recording packaging material usage during the production process and ensuring the correct amount of material is available for reconciliation.
- Inventory Control Team: Responsible for performing the reconciliation process, ensuring that the physical stock matches the usage data, and updating inventory records accordingly.
- Production Manager: Responsible for overseeing the reconciliation process and ensuring that any discrepancies are investigated and resolved.
- Quality Control (QC): Ensure that the reconciliation process follows SOPs and complies with GMP regulations, especially when discrepancies occur.
4. Accountability
The Production Manager is accountable for ensuring that the reconciliation process is carried out effectively and promptly after each production batch. Any discrepancies found during reconciliation should be reported to the QA team for further investigation.
5. Procedure
5.1 Preparation for Reconciliation
- At the end of the production batch, gather all packaging materials used during the process (e.g., cartons, labels, blister packs, seals) (Annexure-1).
- Verify that the packaging material usage records are complete and accurate, as recorded during the production run (Annexure-2).
- Ensure that all leftover packaging materials are properly stored and accounted for (Annexure-3).
5.2 Material Count and Inventory Update
- Physically count all packaging materials that were used during production, and compare them with the recorded quantities (Annexure-4).
- Verify that all materials are used according to the production plan. If there are discrepancies, identify the cause and investigate (Annexure-5).
- Update the inventory records with the actual usage quantities, including any discrepancies or adjustments (Annexure-6).
5.3 Reconciliation of Leftover Packaging Materials
- Reconcile any unused packaging materials and determine whether they can be reused or should be discarded (Annexure-7).
- If materials are to be reused, they must be inspected for damage and quality before being returned to stock (Annexure-8).
- Record all leftover materials and update the inventory to reflect the remaining stock accurately (Annexure-9).
5.4 Discrepancy Investigation
- If discrepancies are found during reconciliation, investigate the root cause. This may involve checking records, reviewing usage logs, and speaking with the operators (Annexure-10).
- Document the findings and corrective actions taken (Annexure-11).
- Report significant discrepancies to the Production Manager and QA for further review and corrective action (Annexure-12).
5.5 Documentation and Record-Keeping
- Document all reconciliation activities, including material usage, leftover materials, discrepancies, and corrective actions (Annexure-13).
- Ensure that all reconciliation records are maintained according to company policies and retained for the required period (Annexure-14).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FIFO: First In, First Out
7. Documents
- Packaging Material Usage Log (Annexure-1)
- Material Usage Record (Annexure-2)
- Leftover Material Log (Annexure-3)
- Physical Material Count Log (Annexure-4)
- Discrepancy Log (Annexure-5)
- Inventory Update Record (Annexure-6)
- Leftover Material Inspection Log (Annexure-7)
- Material Reconciliation Report (Annexure-8)
- Corrective Action Log (Annexure-9)
- Reconciliation Investigation Log (Annexure-10)
- Discrepancy Investigation Report (Annexure-11)
- Report of Corrective Actions Taken (Annexure-12)
- Reconciliation Documentation Log (Annexure-13)
- Packaging Material Records Retention Log (Annexure-14)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
- ISO 9001 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Packaging Material Usage Log
| Material Type | Quantity Used | Batch Number | Operator |
|---|---|---|---|
| Blister Packs | 5000 | Batch 12345 | John Doe |
Annexure-2: Material Usage Record
| Material | Quantity Used | Production Date | Operator |
|---|---|---|---|
| Cartons | 1000 | 01/07/2026 | Jane Smith |
Annexure-3: Leftover Material Log
| Material | Quantity Leftover | Batch Number | Disposition |
|---|---|---|---|
| Blister Packs | 500 | Batch 12345 | Reused in next batch |
Annexure-4: Physical Material Count Log
| Material Type | Quantity Counted | Batch Number | Operator |
|---|---|---|---|
| Cartons | 1000 | Batch 12345 | John Doe |
Annexure-5: Discrepancy Log
| Material Type | Quantity Discrepancy | Batch Number | Investigation Outcome |
|---|---|---|---|
| Blister Packs | 50 | Batch 12345 | Found during reconciliation; reported for further investigation |
Annexure-6: Inventory Update Record
| Material | Initial Quantity | Quantity Used | Quantity Leftover | Updated Quantity |
|---|---|---|---|---|
| Cartons | 1500 | 1000 | 500 | 500 |
Annexure-7: Leftover Material Inspection Log
| Material | Quantity Leftover | Inspection Date | Inspector | Inspection Result |
|---|---|---|---|---|
| Blister Packs | 500 | 02/07/2026 | Jane Smith | Pass; suitable for reuse |
Annexure-8: Material Reconciliation Report
| Material Type | Initial Quantity | Quantity Used | Quantity Leftover | Discrepancy |
|---|---|---|---|---|
| Cartons | 1500 | 1000 | 500 | None |
Annexure-9: Corrective Action Log
| Issue | Action Taken | Responsible Person | Date |
|---|---|---|---|
| Material Discrepancy | Rechecked material counts and updated inventory records | John Doe | 02/07/2026 |
Annexure-10: Reconciliation Investigation Log
| Discrepancy Found | Investigation Date | Responsible Person | Investigation Outcome |
|---|---|---|---|
| 50 blister packs missing | 02/07/2026 | Jane Smith | Reported to QA for further investigation |
Annexure-11: Discrepancy Investigation Report
| Discrepancy | Investigation Outcome | Corrective Action Taken | Investigated By |
|---|---|---|---|
| Missing Blister Packs | Inventory was updated incorrectly due to data entry error | Updated inventory records and cross-checked against production data | John Doe |
Annexure-12: Report of Corrective Actions Taken
| Corrective Action | Action Taken | Action Date | Responsible Person |
|---|---|---|---|
| Material Discrepancy | Rechecked stock, reconciled inventory | 02/07/2026 | Jane Smith |
Annexure-13: Reconciliation Documentation Log
| Document Type | Document Reference Number | Document Date |
|---|---|---|
| Reconciliation Report | RECON-12345 | 02/07/2026 |
Annexure-14: Packaging Material Records Retention Log
| Material Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Cartons | 5 years | John Doe | Storage Area A, Shelf 3 |
15. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New procedure | QA Head |
| 01/07/2026 | 2.0 | Updated reconciliation procedures and reporting logs | Process optimization and addition of new corrective action procedures | QA Head |