The residual solvents case. The impact industry can have on these public standards by taking advantage of the commenting process can be demonstrated by reviewing the steps associated with the adoption of the new residualsolvents requirements.Residual-solvent revisions began in 1988 when USP proposed a general test chapter for organic volatile impurities (OVI), ultimately adopted in 1990. In 1997, the International Conference on Harmnization ICH) finalized Q3C Guideline for Residual Solvents. The European Pharmacopoeia (Ph. Eur.) subsequently adopted this guideline in 2000. In 2003, USP published a proposal to align the OVI chapter with the ICH and Ph. Eur. documents. The official adoption date for this revision was set for April 1, 2004, but feedback from industry prompted a major revision, ultimately delaying adoption of the standard.
Revised monographs. Industry has been commenting to USP for many years that its monograph format is difficult to decipher. Many companies have transcribed monographs into their standard operating procedures so that analysts can easily understand and perform the required tests. Other companies have used the Ph. Eur. monographs, commenting to USP that the European style is easier to follow.
USP listened to these concerns and unveiled plans to redesign the format of its monographs by the time the 2010 edition of the USP–NF is issued. Over the past two years, the organization has been rewriting some 3000+ monographs in the new format. Because of the enormous volume of work associated with translating test procedures, there are bound to be occasional errors. Industry can help eliminate potential errors before the transcribed monographs become official by performing a technical review of the monographs' contents. USP has posted completed redesigned monographs on its website for this purpose.
Future benefits. The public-review process is an important mechanism for USP to obtain necessary feedback from industry regarding changes to its official standards. Participation is optional, but having a say in the quality of the standards one uses in everyday testing is clearly beneficial. In December, Pharmaceutical Technology held a webcast ( http://PharmTech.com/usp61) on potential implementation issues associated with USP's microbiological testing chapters, which become official in May. In the September/October 2008 edition of Pharmacopeial Forum, USP published a paper on potential revisions to the heavy-metals test chapter. Now is the time to comment on both. It is only through the proactive participation that everyone in industry can be assured USP standards are appropriate and applicable to their work.
Susan J. Schniepp is a pharmaceutical consultant at Schniepp & Associates, LLC, 379 Burroughs Rd., Boxborough, MA 01719, [email protected]