Master Validation Plan

The MVP is a document, or group of documents that detail and discuss the validation activities and compliance requirements within regulated business such as manufacturing, tissue banking, medical device, pharmaceutical and biotech companies. The underlying message of a MVP is that the organization is quality-driven, and that they maintain control of their quality system.

The MVP essentially is a summary of the validation strategy, and it is critical for regulated industries that follow FDA Good Manufacturing Practices (GMP). The MVP is critical for the success of heavily regulated businesses. FDA inspectors will often ask for the validation documentation within an organization, including equipment validation and the overall validation plan.

The elements of a Master Validation Plan include:

• A description of the organizations validation policy
• A list of all validation activities within the scope of the plan
• Validation plan schedules
• The status of validation activities within the scope