Challenges and industry participation
While the vision of harmonization is simple and straightforward, execution presents an array of challenges—some more easily
addressed than others. Chief among these is differences in the regulatory and legal requirements of each country—which can
make full harmonization difficult, or even impossible. Both JP and EP fall under ministerial bodies with a direct link to their respective regulatory agencies, while USP is an independent group
separate from the FDA. To the degree possible with these constraints, PDG has managed to produce encouraging results. One
approach is harmonization by attribute, which moves items forward where there is significant agreement on the main attributes
(e.g., definition, assay, and identification testing), even if other portions of a standard are in dispute. This also allows
PDG to avoid spending resources on topics where there are insurmountable differences, and focus on items where there is progress.
Another challenge is the time required to bring harmonized monographs and chapters to public status. Although the seven-stage
process will likely never be considered speedy, PDG is taking strides to move more efficiently.
Other challenges could be more easily addressed, such as by earlier and increased industry participation. Frequently, the
potential for harmonization has not been realized by manufacturers and other stakeholders until late in the process. Moreover,
comments to proposals published in Pharmacopeial Forum (PF), the online vehicle through which USP accepts feedback on standards, has often been received too late to be considered. Unlike
the inherent challenges identified above, these are conquerable. USP has intensified educational and outreach activities to
industry through free webinars, a dedicated webpage that centralizes and simplifies information
http://(www.usp.org/USPNF/pharmacopeialHarmonization/) and activities. Moreover, USP began to offer PF free to all in January 2011, eliminating any barriers to accessing the journal (
http://www.usp.org/USPNF/pf/).
Industry participation is crucial for harmonization to achieve its ultimate potential. Most vital is for manufacturers to
take notice of harmonization proposals in PF at Stage 4 and submit comments to USP. If there are implementation problems with the methods proposed by PDG, USP must hear
from industry at this stage. Given that manufacturers and users will be required to comply with the eventual standard, active
engagement benefits all parties.
Hot topics and future work
PDG's workplan includes a variety of hot topics. Examples include the development of general chapters on elemental impurities,
viscosity determination for excipients, and the strengthening of selected high-risk monographs to control for economically
motivated adulteration. Also, PDG is looking at process and other potential improvements (e.g., accelerating harmonization).
Harmonization is frequently cited as an essential activity but it desperately needs the full commitment of all parties if
its promises and potential are to be realized.
Anthony DeStefano, PhD, is vice-president of general chapters, and Kevin Moore, PhD, is scientific liaison, both with the US Pharmacopeial Convention (USP).
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