Process Validation Procedures for MDIs

1) Purpose

The purpose of this SOP is to establish procedures for conducting process validation for the manufacturing of metered-dose inhalers (MDIs) to ensure consistency, reliability, and compliance with regulatory requirements.

2) Scope

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

3) Responsibilities

The responsibilities for this SOP include planning validation studies, executing validation protocols, analyzing validation data, and documenting validation activities. Specific roles include:
Production Engineers: Implement validated processes in production operations.
Quality Assurance Personnel: Review and approve validation protocols and reports.
Validation Specialists: Conduct validation studies and analyze validation data.

4) Procedure

4.1 Process Validation Planning
4.1.1 Define the scope and objectives of process validation studies.
4.1.2 Identify critical process parameters (CPPs) and critical quality attributes (CQAs).
4.2 Protocol Development
4.2.1 Develop validation protocols detailing study objectives, test methods, acceptance criteria, and sampling plans.
4.2.2 Obtain approval of validation protocols from relevant stakeholders.
4.3 Process Qualification
4.3.1 Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)