Calculate your potential savings with our ROI Calculator
ROI CalculatorA Validation Master Plan (VMP) is a strategic document that describes the overall validation policy for an organization, sets out the testing limits, provides the methodology, and plans for the use of resources necessary to validate that all facilities, utilities, equipment, and computerized systems perform consistently within a validated state.
Performance Qualification (PQ): Process Consistency
Operational Qualification (OQ): Functional Limits
Installation Qualification (IQ): Physical Verity
VMP is the strategic baseline and is an umbrella document.
Industries that are heavily regulated, like the life sciences, include the pharma and biotech sectors as well as medical devices; an organization cannot merely activate its manufacturing line and produce products commercially. Everything from the environment, HVAC systems, purified water systems, automated application software, and process equipment needs to be validated to show that it produces outputs within stringent quality standards. The Validation Master Plan is considered the inclusive document in ensuring all this happens.
The objective behind creating a VMP is to introduce total structure, clarity, and uniformity in the process of validation throughout its entire lifecycle. Rather than letting the respective engineering teams qualify components using a non-standardized approach, the VMP calls for templates, standardized criteria for accepting the qualification results, as well as specific rules for assessing the risks involved. As it is a comprehensive document, it also represents a necessary requirement on the part of global regulatory agencies like the EMA and FDA in terms of their cGMP annexes on validation. Failure to comply with the requirements of having a fully developed and validated VMP leaves the plant out of control.
The proper construction of the Validation Master Plan should have a structure that is easy and comprehensive enough to include all aspects of the business:
Validation Policy and Scope: This is the initial introduction part that sets forth the policy commitment of the company to validation compliance, the precise physical borders of the facility to be reviewed and specifies the inclusion and exclusion criteria with regards to the system validation, depending upon their effect on the product quality.
Organizational Roles and Responsibilities: The explicit organizational matrix delineates the hierarchy with respect to validation implementation. This part of the plan identifies who writes, performs, verifies data entry, and approves validation activities within the QA function.
Risk-Based Impact Assessment: It is a technical approach wherein all equipment, utilities, and computerized systems are classified into three groups: “Direct Impact,” “Indirect Impact,” or “No Impact.” Systems having a direct impact, such as a sterile autoclave and tableting machine, have to undergo a rigorous validation process while indirect systems follow routine commissioning.
The Qualification Matrix (IQ/OQ/PQ): It is the crux of the plan in which the facility describes how it will perform IQ (installation qualification to establish proper installation), OQ (operational qualification for system performance test at extreme operational range) and PQ (performance qualification for process validation).
It is essential that a VMP be dynamic to adjust itself to any changes that occur in the manufacturing facility. For example, when equipment is altered, or standard operating procedures are modified, or parts have to be changed due to preventative maintenance, the qualified status of a system naturally falls under potential threat. In this case, an efficient VMP needs to provide a clear ‘Change Control System’ and a ‘Re-Validation Policy’.
The plan should define the extent of alteration in a facility that would necessitate the requalification and thus prevent any unauthorized changes from interfering with the baseline. A regular review period should be mandated in the VMP to conduct an evaluation of all the data on equipment performance, measurement inaccuracies, or deviations in processes. Reviewing the above data on a yearly basis will ensure that systems are always within their limits of qualification.
