Standard Operating Procedure for Material Reconciliation During Tablet Manufacturing
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/184/2025 |
| Supersedes | SOP/TAB/184/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To establish the procedures for material reconciliation during tablet manufacturing to ensure accurate tracking of all materials used in the production process and ensure compliance with regulatory requirements.
2. Scope
This SOP applies to all materials used in the tablet manufacturing process, including active pharmaceutical ingredients (APIs), excipients, and packaging materials. It covers material usage, wastage, and inventory reconciliation from the start of production to the final product.
3. Responsibilities
- Quality Assurance (QA): Responsible for overseeing material reconciliation processes, ensuring that all materials used are properly accounted for, and discrepancies are investigated.
- Production Team: Responsible for providing accurate records of materials used, quantities, and wastage, and for reporting any discrepancies in material usage.
- Warehouse Team: Responsible for ensuring that materials are accurately stocked and that proper documentation is maintained for material transfers.
- Inventory Control: Responsible for maintaining the records of raw materials and finished goods, ensuring that any discrepancies in material quantities are identified and investigated.
4. Accountability
The QA Manager is accountable for ensuring that the material reconciliation process is followed accurately, that discrepancies are resolved promptly, and that accurate records are maintained throughout the production process.
5. Procedure
5.1 Material Issuance
- Ensure that all materials required for production are issued according to the material requisition form.
- Verify the quantities of raw materials, APIs, excipients, and packaging materials against the requisition list and update the inventory system accordingly.
- Record the issued material details, including batch numbers, quantities, and any other relevant data in the material usage log (Annexure-1).
- Ensure that materials are issued in accordance with the production schedule and that any changes are properly documented.
5.2 Material Usage Monitoring
- During tablet manufacturing, monitor and record the actual quantities of materials used in the production process.
- Note any wastage or rework materials generated during the process, and document the reasons for these discrepancies (e.g., process loss, machine issues) (Annexure-2).
- Ensure that wastage is within acceptable limits, and if it exceeds the defined threshold, investigate the cause and take corrective actions.
5.3 Material Reconciliation
- After each production batch is completed, perform a reconciliation of the materials used with the original quantities issued.
- Compare the quantities of raw materials used, wastage, and final tablet production against the quantities issued and update the inventory accordingly.
- Calculate the material yield, which should account for all usage, wastage, and final product yield. Any significant discrepancies must be investigated (Annexure-3).
- If there are discrepancies between the quantities issued and the quantities used, notify QA and investigate the potential causes, including issues such as measurement errors, incorrect material issues, or process inefficiencies.
5.4 Discrepancy Investigation
- If discrepancies in material usage or wastage are identified, conduct an investigation to determine the root cause.
- Review all material handling, storage, and manufacturing records to identify potential areas for improvement.
- Investigate any discrepancies in the issuance process, including whether the correct quantities were issued or if there was an error in the material receipt process (Annexure-4).
- Investigate any potential operational issues, such as incorrect weighing or measuring of materials, process losses, or equipment malfunctions.
- Corrective actions should be taken to address the root cause of any discrepancies and prevent recurrence.
5.5 Documentation and Record Keeping
- Maintain accurate records of material usage, wastage, and reconciliation for each production batch (Annexure-1, Annexure-2, Annexure-3, and Annexure-4).
- Ensure all records are signed and dated by the responsible personnel to confirm the accuracy of the information.
- Store all material reconciliation records securely and retain them for at least five years or as required by regulatory guidelines.
5.6 Reporting
- Report material discrepancies and corrective actions taken to senior management for review and decision-making.
- Provide quarterly reports on material reconciliation and any corrective actions taken to ensure ongoing compliance with material management procedures.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- RPN: Risk Priority Number
- CAPA: Corrective and Preventive Action
7. Documents
- Material Usage Log (Annexure-1)
- Material Wastage Log (Annexure-2)
- Material Reconciliation Report (Annexure-3)
- Discrepancy Investigation Report (Annexure-4)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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 Usage Log
| Batch Number | Material Name | Quantity Issued | Quantity Used | Wastage |
|---|---|---|---|---|
| Batch-12345 | API-123 | 1000 kg | 980 kg | 20 kg |
Annexure-2: Material Wastage Log
| Batch Number | Material Name | Wastage Reason | Wastage Quantity |
|---|---|---|---|
| Batch-12345 | API-123 | Process Loss | 20 kg |
Annexure-3: Material Reconciliation Report
| Batch Number | Material Name | Issued Quantity | Used Quantity | Reconciliation Status |
|---|---|---|---|---|
| Batch-12345 | API-123 | 1000 kg | 980 kg | Reconciled |
Annexure-4: Discrepancy Investigation Report
| Batch Number | Discrepancy Description | Investigation Findings | Corrective Actions | Completion Date |
|---|---|---|---|---|
| Batch-12345 | Discrepancy in material usage | Measurement error during production | Re-calibrated equipment and retrained personnel | 15/04/2026 |
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 material reconciliation process | Improved tracking and reporting of discrepancies | QA Head |