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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.
The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.
I have been participating in activities of the US Pharmacopeia (USP) for several years, and I am continually disappointed by those in industry who claim that USP's standards are antiquated. The USP process is voluntary and relies on industry participation for setting, updating, and maintaining its monographs. By taking a proactive role in helping to establish the specifications, test procedures, and general test requirements published in USP, industry can have a voice in setting standards and ensuring those standards are appropriate for their intended purpose.
Susan J. Schniepp
It is especially critical for industry to participate in the USP public review and comment process when the proposed revisions impact a broad range of products. The pharmacopeia recently adopted, for example, new requirements for residual solvents that took effect July 1, 2008. There are many other proposed changes that will affect broad-scope procedures and methodology such as harmonizing the chapters for microbiological tests with the European and Japanese Pharmacopoeias, making revisions to the heavy-metals test chapter, and redesigning monograph formats.
Figure 1: The US Pharmacopeia review-and-comment process.
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.
The original USP proposal for residual solvents would have changed every monograph to include a line item for residualsolvent testing. Industry publicly commented that this requirement would result in unnecessary testing. Based on the public feedback, USP revised its initial proposal and formed a project team, involving the pharmaceutical community, to make new recommendations. The collaborative effort culminated with the adoption of the new standard last July, with little or no comment from industry. Although some concerns remain among industry, they are related more to the standard's applicability than to its content.
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 (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, firstname.lastname@example.org.