1) SOP for Reconciliation of Materials
2) Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the steps required to reconcile the quantities of raw materials used in production with the planned quantities and the remaining inventory to ensure accurate inventory management and compliance with regulatory requirements.
3) Scope
This SOP applies to all personnel involved in the material reconciliation process within the pharmaceutical manufacturing facility.
4) Responsibilities
- Production personnel are responsible for accurately documenting the usage of raw materials during production.
- Warehouse personnel are responsible for tracking inventory levels and reporting discrepancies.
- Quality Assurance (QA) personnel are responsible for overseeing the reconciliation process and ensuring compliance with this SOP.
- Supervisors are responsible for reviewing and approving reconciliation reports.
5) Procedure
- Recording Material Usage
- At the beginning of each production batch, record the starting inventory of each raw material to be used.
- During production, document the quantities of each raw material used in the batch records.
- At the end of production, record the remaining quantities of each raw material.
- Calculating Material Reconciliation
- Compare the recorded starting inventory, quantities used, and remaining inventory for each raw material.
- Calculate the expected remaining inventory by
subtracting the quantities used from the starting inventory.
Document any discrepancies between the expected remaining inventory and the actual remaining inventory.
Investigating Discrepancies
Review and Approval
Documentation and Archiving
Periodic Review
- If discrepancies are identified, investigate potential causes, such as measurement errors, recording errors, or material losses.
- Document the findings of the investigation and any corrective actions taken to resolve the discrepancies.
- Update the inventory records to reflect any adjustments made during the investigation.
- Submit the reconciliation report, including any documented discrepancies and corrective actions, to the supervisor for review.
- The supervisor reviews the reconciliation report and approves it if the discrepancies have been adequately addressed.
- If further action is required, the supervisor assigns additional tasks to resolve any outstanding issues.
- Ensure that all records related to the material reconciliation process, including batch records, inventory logs, and investigation reports, are accurately documented.
- Store the reconciliation records in the designated location for future reference and audits.
- Maintain records in compliance with regulatory requirements and company policies.
- Conduct periodic reviews of the material reconciliation process to identify trends, recurring discrepancies, and opportunities for improvement.
- Implement any necessary changes to the reconciliation process based on the findings of the periodic review.
6) Abbreviations, if any
- SOP: Standard Operating Procedure
- QA: Quality Assurance
7) Documents, if any
- Batch Records
- Inventory Logs
- Reconciliation Reports
- Investigation Reports
8) Reference, if any
- Current Good Manufacturing Practice (cGMP) guidelines
- Company-specific inventory management and reconciliation guidelines
9) SOP Version
Version 1.0
