Manufacturing

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.

Cold Chain: Going the Extra Mile

Siemens and ADENTS develop joint solution for drug serialization challenges.

Adents, Siemens Team on Serialization Solution

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.

Serialization: Getting Past the Quick Fix

The Safe Chain Track and Trace System automates traceability for supply chain security.

System Automates Traceability

CSafe partners with Lufthansa Cargo in dedicating a fleet of RKN containers to Cool/td-Active service offering.

Lufthansa Cargo Offers CSafe Containers

UPS’ 2015 “Pain in the Chain” survey suggests that pharma companies are getting better at product protection, cold chain and regulatory compliance, but need to improve cost control and planning for unexpected events. Lack of transparency and “too many handoffs” remain major challenges.

Pharma Supply Chains:  Contingency Planning Not Yet a Priority, Survey Says

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

Piloting Track-and-Trace Implementation

Citing compliance issues, FDA extends deadline for product tracing information requirements for dispensers to March 1, 2016.

FDA Extends Compliance Dates for Drug Dispensers

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) 

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.