Standard Operating Procedure for Batch Reconciliation in Granules Production
1) Purpose
The purpose of this SOP is to provide guidelines for conducting batch reconciliation in granules production within the pharmaceutical industry to ensure accurate documentation of material usage and reconciliation of discrepancies.
2) Scope
This SOP applies to all personnel involved in the production and reconciliation of batches in the granules manufacturing department.
3) Responsibilities
Production Supervisor: Responsible for overseeing batch reconciliation and ensuring accuracy.
Quality Assurance (QA) Officer: Responsible for reviewing batch reconciliation reports and ensuring compliance with SOPs.
4) Procedure
- Preparation Before Reconciliation:
- Collect all relevant documents including batch records, packaging records, and material reconciliation forms.
- Ensure availability of accurate weighing and measuring equipment.
- Material Usage Documentation:
- Review batch records to document actual quantities of raw materials used.
- Record any discrepancies or deviations encountered during material usage.
- Reconciliation Calculation:
- Calculate total quantities of each raw material used based on batch records and reconciliation forms.
- Compare calculated totals with initial quantities dispensed to identify any discrepancies.
- Resolution of Discrepancies:
- Investigate and document reasons for discrepancies (e.g., spillage, loss during processing).
- Take corrective actions as necessary and document these actions.
- QA Review and Approval:
- Review the completed batch reconciliation report for accuracy and completeness.
- Obtain QA approval before finalizing and filing the reconciliation report.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Batch Records, Packaging Records, Material Reconciliation Forms, Corrective Action Reports
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines for pharmaceutical manufacturing.
8) SOP Version
Version 1.0
