USP, FDA update quality standards for common drugs

The U.S. Pharmacopeial Convention is working with the FDA and the Consumer Healthcare Products Association to update the quality standards for common medicines. It's part of a USP plan to assess drug data in the USP and National Formulary compendia, with an eye toward updating test procedures to keep pace with technology. On the common-medication list is acetaminophen, among the highest-volume OTC drugs and also used in prescription meds.

The FDA has recommended a test for impurities and degradants in products containing the ingredient.

USP teaming with FDA and CHPA to apply modern test methods to acetaminophen, other common

As part of its ongoing mission to protect public health, the U.S. Pharmacopeial Convention (USP) is working with the Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) to update quality standards for widely used medicines and ingredients. Several years ago, USP put in place an ambitious, long-term effort to assess written (or documentary) standards for prescription and over-the-counter (OTC) drugs published in the United States Pharmacopeia and National Formulary (USP-NF) compendia, aimed at stepping up the pace of revising test procedures where needed to reflect scientific advances. Coupled with this is USP's ongoing commitment to make available official USP Reference Standards (physical samples) for procedures described in documentary standards.

The working relationships with FDA and CHPA fit into that overall initiative, focusing on an initial list of priority medicines and ingredients identified by FDA. The USP-NF provides specifications for the identity, as well as quality, purity and strength of drugs and their ingredients, which are enforceable by FDA in the United States. USP standards are used in more than 130 countries.

FDA Commissioner Margaret Hamburg, M.D., expressed support for USP's standards modernization project during her remarks at the USP Convention meeting in April of 2010, citing this effort as one of the most pressing tasks facing both USP and FDA given documented incidents of poor-quality prescription and OTC products. Updated test methodologies are crucial to help counter economically motivated adulteration (in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients), and also to address the challenge of impurities that may go undetected with older, non-specific assays and tests.

"FDA and USP have a long-standing partnership in law that helps ensure the quality of the American drug supply," said Roger L. Williams, M.D., USP's chief executive officer. "In the current effort, we are pleased to be joined by CHPA as well, as this initiative would not be possible without the active participation of industry. FDA has identified a number of medications and ingredients commonly used in prescription and OTC products that may be vulnerable to economically motivated adulteration or are associated with other concerns, which has helped focus our efforts. USP is working to make sure the quality standards for these products are based on the best current analytical procedures and allied reference materials to resolve such concerns. American patients, consumers and practitioners have a right to expect this."

In addition to the first list of products and ingredients for USP's priority attention, FDA will continue to recommend candidate standards for updating. An example of an FDA recommendation is a test for impurities and degradants in products containing acetaminophen-one of the highest-volume OTC drugs and one that is also used in many prescription medications. Other commonly used ingredients to be updated include dextromethorphan (a cough suppressant) and diphenhydramine (an antihistamine).

USP will consider all recommendations for updates through its well-established process, in which volunteer experts evaluate standards, solicit commentary from the stakeholder community and ultimately decide on changes to incorporate. USP invites and encourages all stakeholders to provide input into the modernization initiative, and is seeking comment from manufacturers of products and ingredients included in the priority list of standards to be updated-as well as from the practitioner and consumer advocate communities.

FDA's priority list and background information on the standards modernization initiative may be found at www.usp.org/hottopics/monographs.html. Also on this Web page, USP has issued a call for volunteer experts for the Acetaminophen Monograph Expert Panel, which will provide recommendations for revisions to the Expert Committee.

Leading Italian Pharmaceutical Group Deploys TrackWise(R) Solution to Improve Quality Processes

Menarini Group chooses Enterprise Quality Management Solution to manage quality and maintain regulatory compliance

HOLMDEL, N.J., - Sparta Systems, Inc., the maker of TrackWise(R) software and the market leader in enterprise quality and compliance management, today announced that Menarini Group, the world's leading Italian pharmaceutical group, has selected its TrackWise Enterprise Quality Management System (EQMS) to simplify quality processes throughout distributed manufacturing sites. The company will leverage TrackWise software to help achieve the harmonization of quality assurance (QA) processes and availability of critical information for organization-wide regulatory compliance.

The development and production of all pharmaceuticals requires companies to implement meticulous procedures for documentation and auditing to ensure compliance with global regulatory authorities. Often these procedures are in the form of error-prone, paper-based models, making it difficult for companies to reconcile and monitor pharmaceutical quality across more complex global supply chains. As a result, streamlining processes and reducing the cost of compliance while maintaining the highest quality standards is a top priority.

Menarini sought to replace a time-consuming, paper-based and spreadsheet model to track and manage all corporate quality assurance processes. The company selected Sparta Systems' TrackWise software to manage a multitude of QA processes, including deviations, change control, complaint handling and audits. By deploying TrackWise software, the company can harmonize quality procedures between sites, reducing the time spent validating efforts and providing greater insight across the company's global pharmaceutical manufacturing efforts.

"The implementation of TrackWise in up to 14 different plants of the Menarini Group has already resulted in higher workflow efficiency, greater quality event safety and, more strategically, a harmonization between companies throughout our organization," said Dr. Sauro Resti, corporate quality director, Menarini Group. "The system's full configurability allows us to implement in several countries simultaneously without revalidating our efforts -- ultimately, reducing the cost of our quality management and compliance efforts across the supply chain."

"In today's complex manufacturing environment, leading pharmaceutical companies like Menarini require a comprehensive view of processes across all locations to improve quality and identify trends and operational risks," said Yaniv Vardi, managing director, Sparta Systems Europe. "As the industry standard for managing quality and compliance at life sciences companies across the globe, TrackWise has helped hundreds of organizations realize the benefits of more effective quality management, resulting in greatly improved operational efficiency and significantly reduced costs."

Aceto Corporation Schedules Fiscal 2009 Third Quarter Financial Results News Release and Conference Call

LAKE SUCCESS, N.Y., - Aceto Corporation (ACET:7.03, -0.39, -5.3%) , a global leader in the sourcing, quality assurance, regulatory support, marketing and distribution of chemically derived pharmaceuticals, biopharmaceuticals, specialty chemicals and crop protection products, today announced that it will issue its financial results of operations for its 2009 fiscal third quarter ended March 31, 2009 before the stock market opens on Friday, May 8, 2009. That morning, at 10:00 am ET, Leonard S. Schwartz, Chairman and CEO, Vincent Miata, President, and Douglas Roth, CFO, will conduct a conference call. Interested parties may participate in the call by dialing 800-264-7882(847-413-3708 for international callers) -- please call in 10 minutes before the call is scheduled to begin and ask for the Aceto call (conference ID # 24377183).