Batch Record Review Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for reviewing batch records in metered-dose inhaler (MDI) production to ensure accuracy, completeness, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in batch record review within the MDI production facility, including quality assurance personnel, production supervisors, and documentation specialists.

3) Responsibilities

The responsibilities for this SOP include reviewing batch records, verifying production data, documenting findings, and ensuring adherence to SOPs. Specific roles include:
Quality Assurance Personnel: Conduct thorough reviews of batch records for compliance and accuracy.
Production Supervisors: Provide batch records for review and address any discrepancies identified.
Documentation Specialists: Maintain batch record documentation and ensure archival according to regulatory requirements.

4) Procedure

4.1 Batch Record Retrieval
4.1.1 Retrieve batch records from production or quality control areas for review.
4.1.2 Ensure availability of complete documentation including production logs, in-process testing results, and equipment usage records.
4.2 Review and Verification
4.2.1 Compare batch records against approved batch manufacturing records (BMRs) and standard operating procedures (SOPs).
4.2.2 Verify completeness, accuracy, and consistency of recorded data, including batch numbers, formulation details, and process parameters.
4.3 Documentation of Findings
4.3.1 Document any discrepancies or deviations identified during batch record review.
4.3.2 Communicate findings to relevant personnel and initiate corrective actions or investigations as needed.
4.4 Approval and Release
4.4.1 Obtain approvals from designated personnel (e.g., quality assurance) before finalizing batch record review.
4.4.2 Release batch records for product disposition or further processing based on review outcomes.

5) Abbreviations, if any

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

6) Documents, if any

Batch record review checklist, batch record templates, approval records, and training documentation should be maintained.

7) Reference, if any

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

8) SOP Version

Version 1.0