Application note: Industry pushes back on USP draft chapter
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>) was put forward by USP experts for industry comment, which ended in November 2020.
The categories drawing responses from an industry perspective include the following:
- (a) opposition to the claim that “autochthonous endotoxin” is necessary to show relevant comparisons with LAL
- (b) confusion brought by the USP description of alternative validation performance that references USP <1223> rather than <1225>
- (c) clarifications sought on the appropriate sample types to be used to demonstrate comparison that has in some cases included natural or pre-treatment waters that contain beta glucans and cellulosic residues that are LAL reactive. The insistence on using this type of water is difficult to understand.
- (d) the need for and level of quality oversight required for recombinantly- produced reagents
- (e) objections to increasing the degree of difficulty of performing alternative validation.