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Original text - English - FDA guidance for industry: PAT

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Category Science

Title
FDA guidance for industry: PAT
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Submitted by mariti
Source language: English

The Agency considers PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.
Remarks about the translation
Tämä on teksti USA:n lääkevalvontaviranomaisen FDA ohjeesta:
Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
12 May 2010 13:30