Regulatory Roundup: USP to Make Pharmacopeial Forum Free Online, And More.

Sep 22, 2010
By PharmTech Editors

The US Pharmacopeial Convention (USP) is transitioning the Pharmacopeial Forum (PF) to a free, online resource as of January 2011. The forum includes proposals for new and revised standards for the official United States Pharmacopeia–National Formulary (USP–NF). The new PF will include only proposals for which USP is seeking public comment, making it easier for users to identify and respond to these proposals, according to a USP press release on the subject. For example, the new version will include articles about standards development, how to use PF, in–process revision, proposed interim revision announcements (IRAs), Pharmacopeial Discussion Group harmonization proposals (Stage 4), and Stimuli articles.

Some items that are currently published in PF will not appear in the new free online version. However, they will be made publicly available on USP’s website. These include policies and announcements, final IRAs, IRA reference standard information, Errata, previous PF proposals still pending, and canceled proposals. The new PF will provide a list of links noting where to find these relocated items.

 

PDA and ISPE are hosting a Washington, DC-based ICH workshop Oct. 6–8, 2010, covering implementation of the quality trio, Q8 Pharmaceutical Development, Q9 Pharmaceutical Risk Management, and Q10 Pharmaceutical Quality System. The workshop will feature members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and include breakout sessions on design space, control strategy, quality system, and risk management. Industry is encouraged to attend.

 

The International Pharmaceutical Supply-Chain Consortium, Rx-360, received good news last week when the Federal Trade Commission said it would not recommend challenging industry’s plans to implement joint supplier and audit programs. Rx-360 has been working for the past 18 months to encourage the sharing of information about supplier audits throughout the global pharmaceutical manufacturing industry.