VMPs As Commitment Documents

One of the many services we provide at Kymanox is commissioning and validation of many different types of systems, from equipment to software. Kymanox not only executes commissioning and validation of systems, but we also create all of the documents to support validation. One of the documents that is usually created to support validation is the Validation Master Plan.

In the pharmaceutical, biotechnology, and medical device industries, it is paramount that the products manufactured are done so under strict guidance and supervision. Quality systems are put into place to ensure the safety and efficacy of the product; while validation ensures that systems, equipment and processes are reproducible and reliable. The Validation Master Plan (VMP) is the primary document that houses all aspects of the validation process and conveys managements overall intent, including defined validation scopes, scheduling of required work and responsible persons.

A VMP is more than a plan for executing validation. It is a commitment from the organization to ensure that the validated systems satisfy regulatory expectations. There various sections in a VMP contain different commitments from the organization. While the VMP is used to plan validation and outline the commitments from the organization, it is also a forward-looking document that must include a commitment for maintaining the validated state of systems in the future, as well as achieving a validated state for systems in the near-term.

COMMITMENTS IN A VMP

The VMP is viewed by regulatory agencies and auditors as a commitment document and is frequently one of the first documents requested in audits. A VMP is an overall commitment to ensure that systems, equipment and processes are validated and in compliance with governmental regulations. It demonstrates that the products manufactured from those systems and processes meet safety and efficacy requirements for the end customer. The subsequent posts to this blog will discuss the following specific commitments made in a VMP:

• A commitment from the management of the organization
• A commitment to how compliance is achieved
• A commitment to properly planning all aspects of validation
  

Any comments or questions are welcomed.

Best regards,

Justin Pawlik