Supply Chain

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.

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.

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

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

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

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

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

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.

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.

WuXi PharmaTech and TruTag Technologies successfully applied and detected TruTag's edible microtags on solid-dosage drug products and found no effect on dissolution.

Choosing the correct shipping solutions, including packaging, transportation mode, and monitoring, helps mitigate the risks inherent in global logistics.

FDA and industry support global framework and collaborations to secure the supply chain.

Cloud computing has made it easier for pharma companies and their contract partners to gain visibility into their combined supply chains.

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.

CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.

The agency requires early notification of potential drug shortages.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

A 25,000-sq-ft cargo facility at Philadelphia International Airport offers different levels of temperature storage.

Bylo has been selected to lead the GS1 Healthcare US Industry Initiative, focused on driving adoption and usage of GS1 Standards in healthcare.

The European Medicines Verification Organization has signed agreements with service providers to establish blueprint systems in compliance with the Falsified Medicines Directive.

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

The agency takes action against websites that illegally sell unapproved medications.

Senior Editor Agnes Shanley reviews key points pharma companies should address to meet global requirements for pharma supply chain safety. Hear how pharma companies can address the concerns such as drug counterfeiting, adulteration, and drug shortages.

Supply chain consortium establishes a working group to address quality problems in India.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Compliance with the new traceability requirements necessitates an understanding of how and when to begin implementing changes in an ever-evolving industry.

Pharmaceutical companies should take into consideration intellectual property protection when outsourcing the packaging of their products.

Serialization systems can share information between manufacturing and business units, supply-chain partners, and the retail point of sale.