What Is Process Validation?

1.	What Is Process Validation?
Answer» EMA Definition: “Documented evidence that the PROCESS, operated within established parameters, can perform EFFECTIVELY and reproducibly to produce a medicinal product meeting its PREDETERMINED specifications and quality attributes.” USFDA Definition: “The collection and evaluation of DATA, from the process design stage throughout Production, which establishes scientific evidence that a process is CAPABLE of consistently delivering quality product.” EMA Definition: “Documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.” USFDA Definition: “The collection and evaluation of data, from the process design stage throughout Production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

Answer»

EMA Definition: “Documented evidence that the PROCESS, operated within established parameters, can perform EFFECTIVELY and reproducibly to produce a medicinal product meeting its PREDETERMINED specifications and quality attributes.”

USFDA Definition: “The collection and evaluation of DATA, from the process design stage throughout Production, which establishes scientific evidence that a process is CAPABLE of consistently delivering quality product.”

EMA Definition: “Documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.”

USFDA Definition: “The collection and evaluation of data, from the process design stage throughout Production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

What Is Process Validation?

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