What is a Validation Master Plan?

A Validation Master Plan or a VMP is a document that outlines the principles and defines which processes and equipment need to be validated and the order of priority in which the same will be done. Validation of products, processes and facilities is an important part of a company’s Quality Management System(QMS). While the FDA doesn’t necessarily require a Validation Master Plan, it is often included in quality engineering services.A VMP should have logical reasoning for including or excluding every system associated with a validation project based on a risk assessment.
Pharmaceutical, biotechnology and medical device manufacturers are the key sectors that require a VMP. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects.
The VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation.The VMP is crucial from a quality and regulatory-compliance standpoint. At times, FDA inspectors may request documentation outlining an organization’s process and equipment validation plan. Thus, VMPs may help companies overcome challenges.

VMPs should include details of:

  • All prospective, concurrent, retrospective validation and revalidation activities
  • Time, location, priority and order of validation activities
  • A statement describing the validation policy of the company
  • An overview of the organization’s scope of operations, describing the facilities, products and processes
  • Facility management/personnel who have agreed upon the plan
  • Details or copies of any corresponding validation plans, existing SOPs, relevant policy documents and validation reports/protocols, etc.
  • Persons who are responsible and provide approval for SOPs, protocols and the VMP, as well as any review and reference tracking systems
  • References to or appendices detailing any plans for validation training programs.

Developing and implementing a VMP offers numerous benefits to manufacturers. A VMP is documented evidence that the manufacturer follows a well-defined strategy and has their validation process under control. This can be essentially useful during a quality system inspection. The VMP can also enhance business efficiency by preventing product or process failures and improving productivity.
VMP also leads to simplification of the validation process. VMP defines validation strategy and requirements, risk management and implementation. Thus, making the validation process simpler.
Operational excellence also benefits from VMP. A holistic approach helps define how the process will be integrated, how risk management will be applied and how validation will be handled for continuous improvement. It also defines how validation will be performed throughout the project life cycle and through regulatory submissions and other phased approval.
While the need of a VMP is not specifically required, it has become common practice in the pharmaceutical industry. The overall objective of a VMP is to ensure that quality requirements for processes and equipment are consistently met. When applied holistically, a VMP will simplify and standardize validation processes, facilitate continuous improvement and operational excellence, ensure smooth integration into quality systems, support design control and the device life cycle, and improve the overall cost of quality.
In conclusion, Validation is an excellent way to minimize risk and maximize production efficiency and quality. The extra cost incurred for validation is directly proportional to the level of risk aversion. Thus, a suitable validation program devised on pharmaceutical manufacturing standards would help build stability and efficiency.

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