Standard Operating Procedure for Batch Reconciliation in Creams Production
1) Purpose
The purpose of this SOP is to outline the procedures for reconciling materials used during the production of creams to ensure accuracy and traceability of raw materials, intermediates, and finished products.
2) Scope
This SOP applies to all personnel involved in the manufacturing, quality assurance, and quality control of creams, including production operators, QA personnel, and supervisors. It covers the procedures for batch reconciliation from raw material dispensing to finished product packaging.
3) Responsibilities
It is the responsibility of production operators to accurately record all material dispensing, usage, and waste during the production process. QA personnel are responsible for verifying and approving batch reconciliation records to ensure compliance with approved procedures and specifications.
4) Procedure
4.1 Raw Material Dispensing
4.1.1 Retrieve raw materials from approved storage areas according to the batch record instructions.
4.1.2 Weigh and document the quantities of raw materials dispensed, ensuring accuracy and adherence to the approved formulation.
4.1.3 Label containers with appropriate identification and batch numbers before transferring to the production area.
4.2 Manufacturing Process
4.2.1 Record all materials used during the manufacturing process, including active ingredients, excipients, and processing aids.
4.2.2 Document any deviations or adjustments made to the batch formulation during production.
4.2.3 Conduct in-process checks and sampling as per the batch record requirements.
4.3 Waste Management
4.3.1 Collect and document any rejected materials, spills, or unused materials during the manufacturing process.
4.3.2 Dispose of waste materials according to established procedures and environmental regulations.
4.4 Batch Reconciliation
4.4.1 Calculate the total quantity of each raw material used in the batch by reconciling dispensed quantities, materials used in production, and waste.
4.4.2 Verify the accuracy of calculations and ensure all materials are accounted for in the batch reconciliation report.
4.4.3 Compare the reconciled quantities with the batch record to identify discrepancies or deviations.
4.5 Review and Approval
4.5.1 Review the completed batch reconciliation report for accuracy and completeness.
4.5.2 Obtain QA approval of the batch reconciliation report before further processing or packaging.
4.5.3 Investigate and resolve any discrepancies or deviations identified during the reconciliation process.
5) Abbreviations, if any
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Batch Record
Raw Material Specification Sheets
Waste Disposal Records
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0