Supply Chain

Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home. Compliance consultant John Avellanet shares best practices and ways to minimize costs.

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

The company opened a new service center in San Juan, Puerto Rico.

UPS will expand its clinical trial logistics capabilities to include drug and vaccine development.

China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.

Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.

The SmartPak II monitoring system from Cryoport provides information throughout the logistics process.

Recipharm adds hardware, software, and cloud services for serialization compliance processes.

Process analytical technology paved the way for continuous manufacturing.

In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

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.

With deadlines only a few years away, some companies have not started serialization programs, while others are taking a tactical, short-term approach, losing out on potential business benefits.

Air Cargo Community Frankfurt takes steps to make Frankfurt Europe’s largest certified pharmaceutical hub.

Worthington’s CryoScience by Taylor Wharton business will design and manufacture biostorage and logistics equipment for use in Cryoport’s life-sciences cryogenic logistics solutions.

Platinum Press provides serialization-ready printed materials to apply final track-and-trace data onto packaged pharmaceutical products.

Almac partnered with Optel Vision to provide a line-level solution (hardware and software) integrated with Almac’s proprietary level three, site-level software.

By focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.

Technology is making it easier to stop problems before they can affect patients and the bottom line.

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Supply-chain success is measured by how effectively new medications reach patients, and how swiftly manufacturers can react to internal and external changes.

The authors provide their perspectives on shipping validation.

The agency prepares a plan to implement new packaging safety features.

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

Siemens and ADENTS develop joint solution for drug serialization challenges.

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

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

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

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.

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