Catalent Expert Appointed as Chair of the United States Pharmacopeia Packaging, Storage and Distribution Expert Committee
Somerset, NJ, July 15, 2010 — Mary Foster, Pharm.D., Vice President of Quality, has been elected Chair of the United States Pharmacopeia (USP) Packaging, Storage and Distribution Expert Committee (“the Committee”) for the 2010-2015 USP cycle. The United States Pharmacopeia and National Formulary (USP-NF) is the U.S. legally recognized standards compendia for drugs, drug products and dietary supplements. As the Committee Chair, Dr. Foster’s responsibilities will include the creation of new standard USP General Chapters as well as the revision of current standard general chapters. The initial focus of the Committee will be development of standards to guide the pharmaceutical industry in the following subject matter: supply chain – inclusive of drug pedigrees and anti-counterfeiting; testing for extractables and leachables; and testing of glass, plastic and metal container closure systems. The Committee will continue the work on current chapters under revision such as General Chapter <1079> Good Storage and Transportation Practices. Dr. Foster also serves on the USP Advisory Panel for bulk pharmaceutical excipients.
“It is an honor to be elected to the USP Council of Experts Chair of the Packaging, Storage and Distribution Committee. I am committed to creating a collaborative environment as this new expert committee works through the process of developing standard practices and guidance on important topics involving the life cycle of drug products.”
At Catalent, Dr. Foster is responsible for building external relationships with regulatory bodies and pharmacopeia working groups within the pharmaceutical/biotechnology and consumer healthcare industries. Over the 2005-2010 USP cycle, Dr. Foster provided USP committee updates to industry in the US, Canada, the EU and South America and presented at the 2008 and 2009 Annual USP meetings. Dr. Foster routinely presents cGMP training courses in the US, Canada and the 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. Dr. Foster has been with Catalent for 20 years having served in various quality and regulatory roles.
Dr. 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.
Sharon Johnson, Catalent’s Senior Vice President of Quality, said, “We are pleased to be able to have our experts engage with and support critical industry bodies such as the USP, as part of our ongoing commitments to quality and regulatory excellence.”
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,000 people at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion in annual revenue.