Application note: Industry pushes back on USP draft chapter
Posted: 15 February 2021 | Kevin L Williams | No comments yet
Outlining the most common comments from drug manufacturers, the Parenteral Drug Association (PDA) and US Food and Drug Administration (FDA) on the USP draft chapter for recombinant Factor C (<1085.1>).
The USP Draft chapter for recombinant Factor C (<1085.1>) put forward by USP experts for industry comment, which ended in November 2020, included specific points that brought detailed replies shared among drug manufacturers, the Parenteral Drug Association (PDA) and US Food and Drug Administration (FDA). The most common comments among drug companies, the PDA and FDA are outlined here. Of note, the recombinant Factor C test (2.6.32) became an official compendial test in the EU on 1 January 2021, while similar efforts are underway in Japan and China. As a compendial test, Ph. Eur. 2.6.32 does not require the alternative validation that USP draft chapter <1085.1> seeks to enact in the non-binding chapter <1085>.
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Analytical techniques, Endotoxin Detection, Microbiology, Regulation & Legislation
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Hyglos-bioMerieux, Parenteral Drug Association (PDA), US Food and Drug Administration (FDA)
