Supply Chain

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

Eight companies representing the pharmaceutical supply chain have joined a newly founded non-profit membership association, Alliance to Zero, aimed at facilitating the transition of the pharma sector to comply with net-zero emissions.

USP worked with a patient advocacy group and a purchasing organization to create a predictive model for improving supply chain resilience for critical pediatric oncology drugs.

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

Despite the COVID-19 pandemic, the industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.

CalAmp's new sensor for cold-chain applications provides visibility for shipping vaccines.

Drug product security requires anti-counterfeiting techniques such as authentication throughout the supply chain.

The partnership will combine Cold Chain Technologies thermal packaging with B Medical Systems’ stationary refrigeration solutions for temperature-critical pharmaceuticals.

Integrated, paperless data systems can improve efficiency and quality.

More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.

Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.

The Altrui Foundation is a non-profit organization that serves as a center point between manufacturers of unused medications and the charitable organizations that seek them.

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

The company will expand its clinical supply chain services by establishing two new facilities in Rheinfelden and Weil am Rhein, Germany.

A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

End-to-end traceability can provide more value than just securing drug product safety.

Recipharm and BIAL have expanded their long-term supply agreement for the global manufacture and supply of opicapone API.

pci | bridge makes inventory, production, distribution, and shipping data immediately accessible by integrating the platform with PCI’s other systems, making the data manageable from both sides.

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

The companies have signed a definitive agreement to acquire a majority stake of PCI Pharma Services.

Supply chain traceability is essential in the manufacture of APIs to assure safety and quality.