{ENGLISH} CHAPTER 4 VALIDATION AND QUALIFICATION – END

CHAPTER 4 VALIDATION AND QUALIFICATION – END

7. Validation Master Plan (VMP)

The PIC/S guide dives deep into Installation and Operational Qualification (IQ/OQ) and Non-Sterile Process Validation, but it all starts with a crucial document: the Validation Master Plan (VMP). This document serves as a roadmap for the entire validation process, ensuring everything runs smoothly and efficiently.

Why is a VMP Important?

The VMP offers a three-pronged benefit:

Management Clarity: It provides a clear picture of the entire validation program, including the resources (time, personnel, and budget) required. With this information, management can make informed decisions and allocate resources effectively.

Team Alignment:  The VMP acts as a guide for all members of the validation team. It clearly defines their roles and responsibilities, ensuring everyone is on the same page and understands their specific tasks within the validation process.

Transparency for Inspectors: GMP inspectors rely on the VMP to gain a comprehensive understanding of the company’s approach to validation. It demonstrates a well-organized structure for all validation activities, fostering trust and confidence during inspections.

Essential Elements of a VMP (as per EU-GMP Annex 15):

Policy and Structure: This section defines the company’s policy on qualification and validation, outlining roles and responsibilities within the team.

Inventory and Status: It provides a complete list of all facilities, equipment, systems, and processes on-site, along with their current qualification and validation status.

Change Management: This section details how changes and deviations during the validation process will be controlled and managed.

Acceptance Criteria: It offers guidance on developing clear and measurable acceptance criteria for successful validation.

Reference Library: This section…