The Process Validation Master Plan is an overarching document, which covers the overall validation strategy for the manufacture of Molecule X.
The purpose of the process validation master plan (pVMP) is to define the process validation studies required to support licensure of drug substance /product manufacturing in Company X. The pVMP provides a general description of the manufacturing process, outlines the process validation strategy and defines the validation studies that will be conducted to support the full validation of the commercial scale drug substance manufacturing process.
The pVMP will identify a number of documents (Strategies, Protocols/Reports) that describe in more detail execution of this validation strategy and will clearly identify links and inter-dependencies between the documents. Drug Substance process validation is intended to demonstrate that the manufacturing process in Company X, is reproducible, consistent & in control.
This pVMP is prepared in accordance to Company X Quality Standard, and is in compliance with overall FDA rules and guidelines and with the European Commission’s Annex 15.