Standard Operating Procedure for Validation Master Plan

1) Purpose

This SOP outlines the procedures for developing and maintaining a Validation Master Plan (VMP) to ensure that all validation activities are planned, executed, documented, and controlled in a systematic manner to demonstrate compliance with regulatory requirements and ensure the reliability of manufacturing processes.

2) Scope

This SOP applies to all validation activities conducted within the company, including equipment, facilities, utilities, processes, analytical methods, and computer systems, across all departments involved in pharmaceutical manufacturing, quality control, and quality assurance.

3) Responsibilities

The Validation department or designated personnel are responsible for developing, implementing, and maintaining the Validation Master Plan (VMP). Other departments such as Engineering, Quality Assurance (QA), and Production are responsible for supporting validation activities as per their defined roles.

4) Procedure

4.1 Development of Validation Master Plan (VMP)

1. Identify and list all systems, equipment, processes, and utilities requiring validation.
2. Define validation strategies and approaches based on regulatory requirements and industry standards.
3. Document the scope, objectives, and validation activities to be performed for each system or process.

4.2 Validation Protocol Development

1. Develop validation protocols (e.g., IQ, OQ, PQ) based on the VMP and specific validation requirements.
2. Specify acceptance criteria, test methods, and procedures for each validation protocol.

4.3 Execution of Validation