The USP will host the 10th International Symposium on Pharmaceutical Reference Standards in Rockville, MD next week. The meeting will have representatives from China, Japan, Europe and North America in an open forum to discuss compendial issues. The WHO also will be in attendance.
The goal is to increase harmonization across the globe. This year's agenda includes:
- Quality systems expectations
- Complying with global regulation
- Metrological guidance of reference standards
- Control strategies for drug product quality
There are growing concerns regarding the potential for drug ingredient contamination. This is a forum that could allow various global agencies to make sure they are on the same page with regard to regulations covering metal-impurity testing, water for injection production, and residual solvents.
As noted yesterday in a post about the IPC and the USP looking to become more aligned, harmonization is increasingly important to a global pharmaceutical industry. Suppliers of raw materials operate globally but are often forced to adapt locally to test methods and SOPs. Pharmaceutical manufacturers similarly have to adapt test methods and licensing files to local requirements. These steps add a lot of costs that don't add a lot of value and are effectively passed to the patients and healthcare system. Harmonization not only clarifies the rules for all players, but decreases costs and increases efficiencies.
We'll see how the 10th Conference makes out with regard to these outputs.
Posted by Bruce Lehr September 8th 2010.