Validation Master Plan – What You Need To Know

Validation Master Plan – What You Need To Know

Validation, regardless of whether it is of processes, facility or products, is a critical part of a company’s Quality Management System. It holds especially true for those companies that lie within the realm of pharmaceutical, biotechnology or medical device manufacturing.

Though there is no formal requirement for a Validation Master Plan (VMP) as per the FDA Quality System Regulation (21 CFR 820), having a good VMP is critical to executing a solid process validation program. Let us learn more about VMP.

Image license: CC0 1.0 - Public Domain Dedication

What is Validation Master Plan?

A Validation Master Plan (VMP), a part of GMPs (Good Manufacturing Practices) for pharmaceutical, biotech and medical device companies, is a document that outlines and defines the processes and equipment that are to be validated and the priority and order in which this will be done. It also lists who should be responsible for the validation process.

Having a VMP helps you overcome various challenges that you would face in heavily regulated sectors. It is not unusual for FDA inspectors to request documentation that summarizes the organization’s equipment or process validation plan. It is not a formal requirement but having it would definitely help in reducing your chances of receiving an FDA warning letter.

Purpose of a Validation Master Plan

The Validation Master Plan represents the life cycle of the manufacturing validation process. You must create this document concurrently with the design and development effort. You can also use it as a tool for project planning.

The VMP would prove beneficial for planning purposes as it identifies anticipated resource needs and provides key input into the scheduling of project timelines. It also enables you to document the scope of the validation effort, which includes impacted product, procedures, processes, equipment, facilities and utility systems.

Lastly, this document allows you to agree upon and document an overall process and instrument validation strategy. Further, you can provide this to the regulators as it can serve as a clear justification for the validation effect. If you are a medical device manufacturer, the VMP allows you to show that you are in control of the quality system and are producing devices with a focus on product quality.

What Does a Validation Master Plan Comprise of

Ideally, from a risk perspective, the VMP should include an overall assessment of the potential impact of the manufacturing processes on product quality. When you use a risk-based approach, then VMP will identify which processes to validate and in what order to perform the validations.

Additionally, risk assessment also has the potential to identify the processes that don’t need to be validated. You must break down and assess every single manufacturing process in order to understand the impact that each process could have on the final product. Further, this assessment could serve as a strong justification for the scope and requirements that are included in the process validation protocols.

What Should be included in a Good Validation Master Plan

Though VMPs are not a part of the Code of Federal Regulations, here are some details that should be included in it as per the appropriate “Guidance for Industry” recommendations:

  • Every prospective, concurrent and retrospective validation activity
  • Time, location, priority and order of validation activities
  • Details of personnel or facility management who have agreed to the plan
  • A statement describing the validation policy of the company
  • A summary of the scope of operations, with a description of facilities, processes and products
  • Information and details of staff members who are responsible and provide approval for SOPs, protocols and the VMP, and those undertaking the task of reviewing and maintaining reference tracking systems
  • Details or copies of any corresponding validation plans, existing SOPs, relevant policy documents and validation reports/protocols, etc.
  • References to or appendices detailing any plans for validation training programs

If you are a part of the pharmaceutical industry, then undoubtedly quality assurance would rank high your priority list — which is where VMP would be helpful. You could enlist the help of lab calibration services for creating the same.


Author Bio: Edward Simpson works for RS Calibration Services and has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and loves to write about how machines work and about the importance of proper care and calibration of equipment. When he’s not working or writing, he loves to run to stay fit.