Validation Master Plan in the pharmaceutical field

The pharmaceutical industry is one of the most regulated industries in the world, and for good reason: the drugs and treatments it produces have a direct impact on people’s health and well-being.

To ensure that pharmaceutical products are safe and effective, it is essential that all equipment and processes involved in their production are properly validated. This is where the Validation Master Plan (VMP) comes into play.

Plan Maestro de Validación

Validation Master Plan

What is the Validation Master Plan?

The PMV is a strategic document that defines and guides validation activities within a pharmaceutical organization.

Establishes the scope, approach, resources and schedule for specific validation activities, ensuring that all applicable regulations and standards are met.

Key Components of the PMV

All pharmaceutical areas, from research and development to production and distribution, require a systematic and documented approach to validation. The following are the essential phases of the LMP and how they are carried out:

URS (User Requirements):

DQ (Design Qualification):

FAT (Factory Acceptance Test):

SAT (Site Acceptance Test):

IQ (Installation Qualification):

OQ (Operational Qualification):

PQ (Process Qualification):

The Validation Master Plan is essential to ensure that equipment and systems in the pharmaceutical industry meet the highest standards of quality and safety.

Each phase of the PMV is crucial and requires the collaboration of multiple specialties and experts.

At Global, we understand the importance of this process and, as part of our end-to-end service, we are committed to developing and carrying out the entire PMV in close collaboration with the end customer, ensuring that each stage is executed with precision and efficiency, and that all requirements and regulations are met to perfection.