Manufacturing

Anita Szajek is principal scientific liaison at the US Pharmacopeia.

Elaine Gray is principal scientist at National Institute of BiologicalStandards and Control (NIBSC) in the UK.

David Keire is acting laboratory chief, Branch I, Division of Pharmaceutical Analysis, FDA

Barbara Mulloy is visiting professor at Institute of Pharmaceutical Sciences, King’s College London.

Ali Al-Hakim is acting director of Division of New Drug API at the FDA.

Christina Chase is senior scientific writer at US Pharmacopeial Convention (USP).

Monica Da Luz Carvalho Soares is a member of the Deliberative Council of the Brazilian Pharmacopeia at ANVISA and a visiting fellow at the University of Maryland Baltimore County (UMBC).

Damian Cairatti is head of Latin AmericanRegulatory Affairs at USP.

John Hogwood is research scientist at NIBSC.

Paulo MourÃ£o is professor at Federal University of Rio de Janeiro.

Tina S. Morris, PhD, is vice president of Biologics & Biotechnology at United States Pharmacopeia (USP) 

Articles

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

Diversifying the Global Heparin Supply Chain: Reintroduction of  Bovine Heparin in the United States?

Rx-360 announced that Mark S. Paxton has been appointed as the new chief executive office of the international pharmaceutical supply chain consortium. This appointment follows the successful growth of Rx-360 since its foundation in 2009 in the aftermath of the adulterated heparin tragedy. Rx-360 has 300 volunteers from more than 100 institutions that are organized in 17 working groups with activities in the US, Europe, China, and India.

Rx-360 Names Mark Paxton as New CEO

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

Partnering to Address Particulates

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.

FDA Plans Pilot Projects for Drug Supply Chain Security Act

ReposiTrak signs agreement to pilot track and trace system in pharma.

ReposiTrak Announces Track and Trace Agreement

GS1 standard tracks movement and status of goods, enabling better visibility, security and regulatory compliance.

ISO/IEC Approves GS1 EPCIS Standard

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

USP Partners with USAID to Secure Supply Chain

United Cargo signs global rental agreement with va-Q-tec for controlled transport of pharmaceuticals.

United Cargo Adds Temperature-Controlled Units

Virtual pilot programs that simulate scenarios can help the pharmaceutical industry address core issues in the implementation of serialization systems that comply with the US Drug Supply Chain Security Act.

Global Serialization: Could Virtual Pilots Be in Our Future?

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.