A Validation Master Plan or VMP summaries how you will qualify the facility, equipment, process, or product. A VMP is part of your validation program that includes process validation, facility, and utility qualification and validation, cleaning and computer validation, equipment qualification, and so on. It is a key document in the current GMP (Good Manufacturing Practice) regulated pharmaceutical industry.

Validation Master plans help organizations define validation strategies and deliver control over a particular process. The VMP is quite different from a validation process or procedure that explains the specific process to perform validation activities. Your VMP also helps you defines anticipated resource needs and delivers key input into the scheduling of project timelines. It documents the scope of the validation effort such as impacted product, processes, facilities, procedures, equipment, and utilities. Let’s take a look at its functions:

  1. Management education: Top management is not always aware of the real requirements for validations and qualifications. They generally focus on finances and business processes. The VMP helps educate management by presenting a summary assessment of what it will take to get the job done.
  2. Project monitoring and management: It includes validation schedules and the timeline for the completion of the project.
  3. Audit the validation program: It includes all activities related to the validation of processes and the qualification of manufacturing equipment and utilities.
  4. Planning purposes: It defines anticipated resource needs and offers key inputs into the scheduling of project timelines.
  5. Documenting the scope of the validation effort: It says what you plan to do and, most importantly, what you will not do.

 

How to Write A VMP?

Have one lead author write your VMP. Use your experts. A team-writing approach can be beneficial because it allows you to use and learn the skills and knowledge from people from different parts of the operation that increases the assurance that all processes, utilities, equipment, and systems will be addressed. A good VMP is an easy to follow plan.

Just write down what you want to do, how you will do it, what you need to do it, what deliverables you will have, and when you will do it. Remember, the reader did not help you write your VMP, so say what you mean in plain language. Keep in mind that your VMP should be as long as required to present the plan in the necessary detail. A good VMP is your plan for validation success.