Join USP to tackle supply chain threats, extractables and leachables

In its next cycle, the Packaging, Storage, and Distribution Expert Committee of the United States Pharmacopeia (USP) will be addressing some of the challenges the pharmaceutical industry is facing in terms of supply-chain management, testing for extractables and leachables, and testing of glass, plastic, and metal container closure systems. The 2010–2015 committee will be led by chair Mary Foster, Pharm.D., vice president of quality for Catalent Pharma Solutions. “There are no written standards yet by FDA or USP in areas such as anti-counterfeiting, technologies for track and trace, supply chain security and risk mitigation practices, as well as for extractables and leachables testing. This USP Expert Committee will take on the challenge of [issuing] collaborative global decisions for new chapters that will provide guidance in these areas,” she explains. “Companies not already working in these areas will have to be prepared to make critical changes to their processes to ensure the integrity of the products they produce.”

Foster, along with USP staff, has selected 15 members to help create new standard USP General Chapters as well as revise current standards in general chapters. The committee will also continue the work on current chapters under final revisions with feedback from industry such as General Chapter <1079> Good Storage and Transportation Practices. Foster is looking for subject matter experts from around the world that can serve on expert panels to help the committee write new and edit current chapters. “We’ve drawn together experts from industry, academia, and government from around the world, including regulatory agencies such as FDA as expert committee participants, and expert committee members Health Canada and MHRA, with pharma representation from Canada, Germany, India, United Kingdom, and the United States,” she explains. “We are working in a global supply chain so we wanted a global working group. This USP expert committee will benefit from international input, given such work as Health Canada’s recent supply chain management standards and the IATA Chapter 17 work on air transportation of drug products. We expect this collaboration will be worthy of worldwide acceptance to further [harmonize] standard ways of working across the globe. We just have to get this right for effective and efficient handling of drug products for the U.S. market and consideration for worldwide use.”

USP work has closely followed industry trends, but it is now time to get ahead of them, Foster says. For instance, “our intent will be to build upon existing work on the supply chain, but we need guidance to cover the entire contingency as products move from manufacturer to end user,” she says. “Up for debate will be whether the guidance will be a mandatory lower chapter or a voluntary higher chapter.” A second subject, evaluating packages for extractables and leachables, is not adequately covered to guide industry. “Companies have had to set up their own standard of practice,” she continues. “We will bring in experts on glass, elastomers, labeling, desiccants, and any other potential material that could be involved in either an extractable or leachable situation to create a user friendly workable chapter.”

A revision of Chapter <1079> was produced late last year, and comments were provided to the previous committee. The new group will be charged with the formation of an expert panel to take those comments and edit the revision as needed.

At Catalent, Foster is responsible for building external relationships with regulatory bodies and pharmacopeia working groups within the pharmaceutical/biotechnology and consumer healthcare industries. She plans to translate recent work Catalent has completed in developing standard processes for measures and accountability into those the expert committee can use to draft new chapters expeditiously.

Over the 2005–2010 USP cycle, Foster provided USP committee updates to industry in the United States, Canada, the EU, and South America and presented at the 2008 and 2009 Annual USP meetings. Foster routinely presents cGMP training courses in the United States, Canada, and EU.  She is an Advisory Board member of the International Air Transportation Association (IATA) and a member of the Parenteral Drug Association (PDA) Pharmaceutical Cold Chain Interest Group (PCCIG) committee. Foster has been with Catalent for 20 years having served in various quality and regulatory roles. Foster’s nomination follows shortly after the nomination of Stephen Tindal, Director, Softgel Formulation & Operations for Catalent, to the USP Advisory Panel on Liquid Filled Gelatin Capsules.

Foster encourages any subject matter experts to get involved during this next USP cycle. “We need experts to volunteer for our panels, which could be as short as three to six months or as long as a year. We are setting the standards, writing the definitions and writing the industry guidance (with participation from FDA) so if you are the expert, we need to hear from you,” she concludes.

For more information on volunteering to serve as a subject matter expert for the Packaging, Storage, and Distribution Expert Committee, please e-mail Mary Foster at [email protected]. For details on the USP 2010–2015 Council of Experts and its Expert Committees, please visit www.usp.org/goto/councilofexperts.