Next week, the US Pharmacopeia (USP) is hosting the 10th International Symposium on Pharmaceutical Reference Standards in Rockville, MD. The annual PDA-FDA meeting also happens to be taking place next week in Washington, DC, so industry has much to hope for in terms of regulatory news.
The Reference Standards Symposium began in 1996 and is held every one to two years. Traditionally, the event is hosted by a large pharmaceutical company, but in 2008, the pharmacopeial bodies were invited to play a larger role, and the European Directorate for the Quality of Medicines (EDQM), which is responsible for the European Pharmacopeia, hosted the event (a recap can be found here and the proceedings here). Now, it seems, it’s USP’s turn.
The meeting provides representatives of regulatory and standard-setting bodies (including those in Europe, China, Japan, and North America) as well as industry with an open forum to discuss compendial issues, and to network, and share best practices, according to a website about the meeting’s history. The World Health Organization also attends the symposium. The symposium is meant to help guide the pharmacopeias in the making of reference standards and in harmonization efforts.
The agenda for this year covers regulators’ expectations for quality systems, challenges tied to complying with global regulation, the use of metrological principles to guide reference standards, and control strategies to ensure drug product quality (view the full agenda).
This year’s event may be especially important for symposium participants given the various challenges facing the pharmacopeia during the past year. For example, USP had to recall the entire USP 33–NF 28 issue in November 2009 because of errors in the publication. The US-based pharmacopeia is still working on its revision to the metal-impurities chapters (an effort that began back in 1995). ICH has since formed a working group on the same subject, and the European Medicines Agency is simultaneously working on its metal-residue limits.
In addition, industry is watching the European Pharmacopeia closely regarding its decision to allow different techniques for the production of water-for-injection. There are growing global concerns regarding potential drug-ingredient contaminants (e.g., DEG, melamine) and the revision of related standards and monographs.
Although the pharmacopeia have made great progress over the past few years (e.g., quickly revising the heparin monographs and harmonizing pharmacopeial texts through ICH Q4 and its various annexes), there is much to discuss at this year’s symposium. It will be interesting to see what comes out of the meeting.
Editor’s Note: For clarification purposes, the symposium is dedicated to reference materials rather than documentary standards. This blog post was updated Sept. 15, 2010.