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| Validation Master Plan
(VMP)
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The Validation Master Plan (VMP) is the blueprint for a successful validation project. It will define your approach to validation, the applicable references, and the requirements of your GMP system. It will describe the approach to training, the procedures for deviation management, and change control, and establish the responsibilities for your validation project as a whole.
Equipment, processes, and the relevant analytical tests will be listed together with the foreseen protocols for their qualification or validation. This represents a rough risk assessment, in that only the systems and processes considered to have direct impact on product quality are included in the overall validation scope.
Relevant protocols are typically designated:
DQ (Design Qualification)
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)
PV (Process Validation)
CV (Cleaning Validation)
MV (Method Validation)
The VMP will also define the approach to activities like FAT (Factory Acceptance
Test) and SAT (Site Acceptance Test).
The VMP is not only the keystone quality document for your facility and the basis for the planning of your entire project, but is the single most important document to be presented to an external inspector at any phase of the project. The VMP provides a complete overview of the GMP compliant approach to your validation project, and your sequence and schedule of
activities.
Valicare will prepare for you, and your project, a thorough VMP tailored to your project, your product, and your needs. A Valicare VMP is your way ensuring GMP compliant guidance throughout your project, with the flexibility to integrate potential changes of the project scope as they
occur.
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