Standard Operating Procedure for Batch Reconciliation in Gels Production
1) Purpose
The purpose of this SOP is to define the process for accurately reconciling raw materials, intermediates, and final product quantities for each batch of gel produced, ensuring compliance with regulatory requirements and minimizing discrepancies.
2) Scope
This SOP applies to all personnel involved in the production, quality control, and quality assurance of gels within the pharmaceutical manufacturing facility.
3) Responsibilities
Production Operators: Accurately document raw materials used and product yields.
Quality Control (QC) Analysts: Verify material quantities and product yields.
Quality Assurance (QA) Team: Review and approve reconciliation records to ensure compliance and accuracy.
4) Procedure
4.1 Material Issuance
4.1.1 Record the quantities of raw materials issued for each batch in the Batch Manufacturing Record (BMR).
4.1.2 Ensure materials are weighed accurately using calibrated balances.
4.2 In-Process Reconciliation
4.2.1 During production, document any additional materials used or discarded.
4.2.2 Record intermediate yields at critical stages of the manufacturing process.
4.3 Final Yield Calculation
4.3.1 After production, weigh the final product and record the total quantity.
4.3.2 Calculate the theoretical yield based on the initial quantities of raw materials used.
4.3.3 Determine the actual yield and compare it with the theoretical yield to calculate the yield percentage.
4.4 Discrepancy Investigation
4.4.1 If there is a significant discrepancy between the theoretical and actual yields, investigate potential causes such as spillage, waste, or measurement errors.
4.4.2 Document any findings and corrective actions taken to address discrepancies.
4.5 Documentation
4.5.1 Complete the reconciliation section of the BMR, including all calculations and justifications for any discrepancies.
4.5.2 Ensure all entries are signed and dated by the responsible personnel.
4.6 Review and Approval
4.6.1 QA personnel should review the completed reconciliation records for accuracy and completeness.
4.6.2 Approve the batch if the reconciliation is within acceptable limits or document reasons for any deviations.
4.7 Archiving
4.7.1 Store the approved BMR and reconciliation records in a secure location.
4.7.2 Maintain records for the required retention period as per regulatory guidelines and company policy.
5) Abbreviations, if any
SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Batch Manufacturing Record Template
– Reconciliation Worksheets
– Discrepancy Investigation Reports
7) Reference, if any
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA CFR 21 Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
– Company-specific guidelines on batch reconciliation
8) SOP Version
Version 1.0