Supply Chain

Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.

How warehouse execution systems can help in case of a drug recall.

Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.

Alan Kennedy, executive director of TEAM UP, shared perspectives on Poseidon and ocean transport with Pharmaceutical Technology.

Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.

The Multi-Chamber Blister System is a blister package that incorporates Amcor's SafeMix cold form laminate to transport vaccines and sensitive APIs without the need for cool storage.

LogTag has added two new devices to its temperature data logger series.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.

The Tamper Evident Labeller from LSS Labelling Systems Scandinavia is compliant with the European Falsified Medicines Directive.

Pharma Team Up has launched Poseidon, an integrated ocean freight program, to address the disconnect between pharma companies and their logistics providers.

Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.

A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.

Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.

Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.

Oceasoft has updated its line of Bluetooth-enabled temperature data loggers for shipping and logistics applications.

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

Manufacturers and trading partners struggle to meet drug tracking requirements

This article explores some of the challenges, services, and technologies that go into ensuring that vaccines are properly temperature controlled and maintain product integrity for delivery to patients.

Supply Chain Wizard has developed a set of integrated digital solutions to improve supply chain functions.

The Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is compliant with good distribution practices and comes in three models.

Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.

Most pharma supply chain partners believe that manufacturers should pay for blockchain implementations, and own the data.

Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.

Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.

Genentech, AmerisourceBergen, and McKesson are providing pharma user requirements for a new project that will evaluate blockchain‘s potential in meeting requirements of the Drug Supply Chain Security Act, and preventing pharmaceutical counterfeiting.