Process Optimization Procedures for MDIs

1) Purpose

The purpose of this SOP is to establish procedures for optimizing the manufacturing processes of metered-dose inhalers (MDIs) to improve efficiency, product quality, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in process optimization activities within the MDI production facility, including production engineers, quality control personnel, and validation specialists.

3) Responsibilities

The responsibilities for this SOP include conducting process assessments, implementing improvements, monitoring process performance, and documenting optimization activities. Specific roles include:
Production Engineers: Analyze process parameters and implement improvements to enhance efficiency and yield.
Quality Control Personnel: Monitor process changes and verify product quality to ensure compliance.
Validation Specialists: Assess impact of process changes on validation status and regulatory compliance.

4) Procedure

4.1 Process Assessment
4.1.1 Review existing manufacturing processes and identify areas for optimization.
4.1.2 Analyze process data, including batch records, deviations, and quality metrics.
4.2 Optimization Strategies
4.2.1 Develop optimization strategies, including process modifications, equipment upgrades, and procedural changes.
4.2.2 Conduct feasibility studies and risk assessments for proposed process improvements.
4.3 Implementation and Validation
4.3.1 Implement approved