![PAS-X: Weit mehr als ein MES](/fileadmin/_processed_/0/b/csm_Menu-Teaser-Werum-PAS-X-extended_f872e573e2.jpg)
The Food and Drug Administration Safety and Innovation Act (FDASIA) provides the FDA the ability to conduct electronic inspections and target on-site inspections based on metrics. The agency intends to request quality metrics data reports from the industry for a one-year period in electronic format through the FDA Electronic Submissions Gateway (ESG). Analysis of these data – such as the number of lots attempted of a product or the number of specification-related rejected lots of a product, etc. – would be used to grade companies on a curve and to provide them a “grade”, representing their fit on a curve. The FDA would direct resources to those companies who are on the lower end of the curve.
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