Standard Operating Procedure for Batch Reconciliation in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish procedures for conducting batch reconciliation during the production of transdermal patches to ensure accuracy and completeness of manufacturing records.

2) Scope

This SOP applies to batch reconciliation activities performed after completion of each batch of transdermal patches within the production area.

3) Responsibilities

The Production Department is responsible for executing batch reconciliation as per this SOP. Quality Assurance (QA) personnel may oversee and verify reconciliation activities.

4) Procedure

4.1 Initial Preparation

• 4.1.1 Collect all relevant batch records, production logs, and documentation pertaining to the completed batch of transdermal patches.
• 4.1.2 Ensure batch records are accurate, complete, and signed off by responsible personnel at each stage of production.

4.2 Components and Materials Reconciliation

• 4.2.1 Verify reconciliation of raw materials and packaging components used against the quantities documented in batch records.
• 4.2.2 Record any discrepancies found during reconciliation and investigate root causes as per established procedures.

4.3 In-Process and Finished Product Inventory

• 4.3.1 Compare in-process inventory quantities (e.g., semi-finished patches) documented in batch records with physical counts.
• 4.3.2 Conduct final reconciliation of finished product units manufactured against the expected output documented in batch records.

4.4 Documentation Review

• 4.4.1 Review all batch records, reconciliation reports, and related documentation for accuracy and completeness.
• 4.4.2 Ensure that any deviations or discrepancies identified during reconciliation are documented and investigated according to deviation handling procedures.

4.5 Approval and Release

• 4.5.1 Obtain approval from authorized personnel for batch reconciliation and release of transdermal patches for further processing or packaging.
• 4.5.2 Archive reconciled batch records and associated documentation in accordance with established record retention policies.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Batch Records
Reconciliation Reports
Deviation Investigation Reports

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO 13485: Medical devices – Quality management systems

8) SOP Version

Version 1.0