Annual Product Review Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for conducting annual product reviews (APRs) in metered-dose inhaler (MDI) production to evaluate product quality, process performance, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in annual product review activities within the MDI production facility, including quality assurance personnel, production managers, and regulatory affairs specialists.

3) Responsibilities

The responsibilities for this SOP include compiling APR data, analyzing performance metrics, identifying trends, and initiating corrective actions to improve product quality and compliance. Specific roles include:
Quality Assurance Personnel: Lead the APR process and analyze data for product quality trends.
Production Managers: Provide production data and insights into manufacturing processes.
Regulatory Affairs Specialists: Ensure APRs comply with regulatory requirements and guidelines.

4) Procedure

4.1 Data Compilation
4.1.1 Gather production data, quality control records, and batch documentation for review.
4.1.2 Compile APR data including product performance, complaints, deviations, and regulatory updates.
4.2 Performance Analysis
4.2.1 Analyze product quality metrics, process deviations, and compliance with specifications.
4.2.2 Identify trends or recurring issues that may impact product quality or regulatory compliance.
4.3 APR Report Preparation
4.3.1 Prepare APR reports summarizing findings, analysis, and recommendations for improvement.
4.3.2 Include data on batch release rates, stability testing results, and customer complaints in APR reports.
4.4 Review and Approval
4.4.1 Review APR reports with cross-functional teams including quality assurance, production, and regulatory affairs.
4.4.2 Obtain approvals for APR reports and recommendations from management and quality assurance.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
APR: Annual Product Review

6) Documents, if any

Annual product review templates, APR reports, performance trend analyses, and corrective action plans should be maintained.

7) Reference, if any

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

8) SOP Version

Version 1.0