“VMP” stands for “Validation Master Plan,” and it offers a defined blueprint for attaining and maintaining a certified facility by describing the key players engaged in the qualification process, including the areas and systems that will need to be verified. It is essential to have a VMP that includes process validation, facility and utility qualification, and equipment certification and validation, as well as computer validation. The GMP (Good Manufacturing Practice) regulated pharmaceutical business relies heavily on this document since it provides a framework for conducting validation projects in a systematic manner.
It is common for the Food and Drug Administration to evaluate facilities’ validation plans (VMPs) as part of an audit to determine whether or not they are properly thought out and structured. Using a risk assessment, a VMP should justify the inclusion or exclusion of any system in a validation project.
Format
A method to plan creation is recommended by the GAMP 5 standard.
Introduction, scope, duties, facility and design description, building and plant layout, cleanrooms and related controlled environments, storage spaces, staff, personnel, and materials are some of the topics that are often addressed in these types of documents. Validation of products that will be used in the manufacturing process is a key component of building management systems. Manufacturing equipment and building management systems are also key components in the validation of products that will be used in the validation process, as are building management systems and the infrastructure and utilities that support them.
