Batch Reconciliation Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for batch reconciliation in metered-dose inhaler (MDI) production to ensure accurate accounting of materials, components, and documentation throughout the manufacturing process.

2) Scope

This SOP applies to all personnel involved in batch reconciliation activities within the MDI production facility, including production supervisors, inventory managers, and quality control technicians.

3) Responsibilities

The responsibilities for this SOP include reconciling batch records, verifying material usage, identifying discrepancies, and ensuring compliance with SOPs. Specific roles include:
Production Supervisors: Oversee batch reconciliation processes and review reconciliation reports.
Inventory Managers: Monitor material inventory levels and reconcile usage against production records.
Quality Control Technicians: Verify batch reconciliation accuracy and document any deviations observed.

4) Procedure

4.1 Batch Record Review
4.1.1 Retrieve batch records and compare with initial production plans and BMRs.
4.1.2 Verify completeness and accuracy of recorded data, including material quantities and batch numbers.
4.2 Material Usage Verification
4.2.1 Assess material consumption against expected usage rates and reconcile discrepancies.
4.2.2 Document any variances or discrepancies identified during material reconciliation.
4.3 Documentation and Reporting
4.3.1 Prepare batch reconciliation reports detailing findings and corrective actions taken.
4.3.2 Obtain approvals from designated personnel (e.g., quality assurance) before finalizing batch reconciliation.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record

6) Documents, if any

Batch reconciliation templates, reconciliation reports, batch records, and approval documents should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for batch reconciliation requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0