Supply Chain/Logistics

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

Risk management takes center stage, and new mobile apps are being developed to help assess global risks in real time.

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

The authors provide their perspectives on shipping validation.

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

The 2015 UPS supply chain survey suggests that pharma companies need to improve cost control and planning for unexpected events.

The new IVIG products boast improvements in purity, safety, and yield.

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

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

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.

The author explores a dual-supplier sourcing strategy for single-use products and its ability to mitigate business continuity risk.

China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.

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

Adents’ Pharma Suite serialization software features track-and-trace capabilities.

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.

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

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

Manufacturer supply chain needs are changing in response to widening product temperature ranges.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.