JVT

Validation Master Plan (VMP), Part 3: Validation Project Master Plans

ABSTRACT

This discussion continues a series of discussions on types of Validation Master Plans (1).  The previous discussion addressed overview VMPs (2).  The present discussion addresses project VMPs.  The general topic of VMP terminology is a source of confusion in industry meetings and has been requested for further discussion by several validation and quality managers.

Project VMPs described in the present discussion include the following:

  • VMP -- Major Project Document.  This VMP document comprises all information about a specific major validation project at the site such as a new facility addition requiring multiple validation protocols.  For example, a major project VMP would describe validations such as HVAC, Purified Water, equipment, manufacturing, cleaning, and other requirements for validation of the new facility and its future use.
  • VMP -- Single Project Document.  This VMP document comprises all information about a specific individual validation project at the site.  This document is one of the sections in the above-described VMP major project document for an individual validation / qualification.

The site Validation Approval Committee (VAC) has a vital responsibility to the manufacturing site and is critical to the success of the site validation program.  The VAC approves all documents in the above-described VMPs.  The VAC must consider the VMP as “their” document.  Members of the VAC should consider themselves to be a surrogate FDA or other regulatory auditor when they are reviewing the above VMP documents.

This content is only available to IVT members.
Get help maintaining your knowledge . Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.