USP's New (and Burdensome?) Impurity Standards Now Open to Public Comment

The press release has not gone out yet, but USP has posted on its web site (and Tweeted, which is how we found out) that its revised standards for elemental impurities are available for public comment. The standards will be open for industry feedback through next spring.

Also up on the site is a link to FAQ's about the revision. Here's the FAQ that I find most interesting:

Q. Some in the pharmaceutical industry believe that USP is creating unrealistic, unworkable requirements for testing, which could lead to non–compliance and shortages of key medicines. For example, the article published in USP's Pharmacopeial Forum (PF) (2008, 34(5), page 1345) includes a list of 31 substances to be tested. And the proposed limits for each individual element may be unworkable across the many quality assurance labs that would be affected.

A. USP does not intend to burden industry with unwieldy and unnecessary testing requirements. The list in the PF article was intended as a proposal for discussion. As the revision moved forward, that list has been shortened. USP will not mandate the methodology that each lab must use. Manufacturers will have the flexibility to choose a test that best fits their processes.