Validation Master Plan: An Overview  

 

A Validation Master Plan, commonly known as VMP, summaries the principles involved in the qualification of a facility. It also defines the areas as well as systems to be validated and offers a written program to achieve and maintain a qualified facility. A validation master plan or VMP is the foundation for the validation program. It includes process validation, facility and utility qualification and validation, equipment qualification, cleaning, and computer validation, and so on. Validation master plan (VMP) can also define as a key document in the Good Manufacturing Practice (GMP) regulated pharmaceutical industry.

Food and Drug Administration or FDA inspectors look at VMPs during audits in order to figure out whether or not a facility’s validation system is well thought-out as well as organized. It is important that the validation master plan should have logical reasoning for including or excluding systems connected with a validation project based on a risk assessment.

Format

A guide to the validation master planning standard suggests an approach to the creation of the plan. It includes several topics, such as Introduction, scope, description of facility and design,  cleanrooms and associated controlled environments, building and plant Layout, storage areas, gases and vacuum system, personnel, clean steam, personnel and material Flow, responsibilities, infrastructure and utilities, water system, compressed air, water and solid waste handling, list manufacturing equipment, ventilation and air-conditioning system, building management systems, products that are planned to be validated, process validation and cleaning validation approach, qualification/validation approach, microbiological monitoring, calibration, maintenance, computer Validation, related SOPs.

Validation Master Plans

Validation Master Plans discuss validation activities throughout an overall site or within an organization. The Validation Master Plan includes everything about a validation strategy. The process of VMP is to document the compliance needs for the site and to make sure that enough resources are available for validation projects. Sometimes, these plans are written to include specific departmental validation activities or the process of validation for a specific type of system. These plans also define the specific validation process for that group or system type. Master plans are generally written to help an organization with a validation strategy or to offer control over a specific method.

The VMP is different from a validation procedure (SOP). It defines the specific process to perform validation activities. When plans are written for a single validation project, they are known as validation plans. Sometimes, master plans are named for their function area, including a Site Validation Master Plan, Software Master Plan, Pharmaceutical Validation Master Plan, and so on. Let’s check out some examples of the validation master plan, including

  • System, equipment, methods, and facilities and so on that are in the scope of the plan
  • Present validation status for the systems within the project scope
  • Schedule of validation activities
  • Compliance needs for validation, such as how the validation state will maintain

Validation master plans also include:

  • Required validation deliverables
  • Validation documentation format
  • General validation risk mitigation strategy
  • Current validation policies and methods   

Validation master plans or VMP should be approved by the head of Site Quality, along with other senior department heads as appropriate. The approval of senior management is important for validation master plans because their support is necessary for the success of the plan.

If you want to get best-in-class calibration & validation services that enhance integrity & reduce risk, then simply get in touch with the right service provider. There are a number of service providers that offer calibration services along with equipment validation and instrument calibration that ensures your facility stays GLP, GCP, or GMP compliant. 

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