Supply Chain

// November 27, 2023

Building a More Resilient Medicines Supply Chain

In this Q&A with the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium, US Pharmacopeia (USP) policy expert Amy B. Cadwallader highlights the importance of multi-disciplinary, cross-functional coordination to strengthen the medicine supply chain and global public health resilience in the face of ongoing threats, like persistent drug shortages. This Q&A was first published in the Consortium's eNewsletter and is re-printed with the permission of the Duke-Margolis Center for Health Policy.

Amy Cadwallader

Supply Chain

// October 11, 2023

Standards on the Frontlines: Responding to public health crises and strengthening sup...

Vulnerabilities or disruptions to the global medicine supply chain (including drug shortages) continue to make headlines.

Ron Piervincenzi, Ph.D.

Supply Chain

// October 13, 2021

Standards Enable a Strong Medicines Supply Chain

Standards play an important role in the global medicines supply chain, helping governments and manufacturers increase the availability of safe, quality medicines, as well as building patient and health provider trust. In fact, quality standards are a big reason why we in the U.S. can get a prescription filled at our neighborhood pharmacy and trust that the medicine we receive will be safe and work as it should.

Supply Chain

// November 27, 2023

Building a More Resilient Medicines Supply Chain

Amy Cadwallader

Supply Chain

// October 24, 2023

Why cancer medicines are and continue to be vulnerable to drug shortages...

Analysis leveraging USP’s Medicine Supply Map suggests many of the essential cancer medicines have inherently vulnerable supply chains and are at greater risk for shortage compared to other generic medicines.

Vimala Raghavendran Praewpaka Drucker

medicine bottles in a manufacturing plant

Supply Chain

// October 24, 2023

Mitigating Cancer Drug Shortages: USP-American Cancer Society Summit Issues Call to A...

Patient access to cancer drugs can mean the difference between life and death. Persistent shortages threaten patients’ access to the lifesaving and life-sustaining therapies they need.

Anthony Lakavage, J.D.

Supply Chain

// September 21, 2023

Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for D...

Excipients, or inactive ingredients, in a drug formulation are critical components, comprising up to 90% of a drug formulation by volume and serving important functions such as improving stability and increasing bioavailability for targeted drug delivery. However, with so much focus on the quality of active ingredients in the complex pharmaceutical supply chain, the quality of inactive ingredients is, at times, overlooked.

Yognandan Pandya Dr. Catherine Sheehan Jenny (Tong) Liu

Adam Fisher, Ph.D., Director, Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), FDA

Supply Chain

// September 15, 2023

Pharmaceutical Continuous Manufacturing: Regulatory landscape in the spotlight at USP...

The science of pharmaceutical continuous manufacturing (PCM) may not be entirely new but increasing interest in adoption of advanced manufacturing technologies (AMT) including PCM among industry and policymakers in recent years has been accompanied by strong support by FDA.

Dennis Hall

USP’s workshop on “Identifying and Addressing Barriers to Continuous Manufacturing Adoption” July 18-19 in Rockville, Maryland

Supply Chain

// September 15, 2023

Pharmaceutical Continuous Manufacturing: Right for some products, but not all, and hu...

Pharmaceutical continuous manufacturing (PCM) is suitable for some medicines, but not every product or situation, and potential hurdles abound, participants generally agreed at USP’s workshop on “

Dennis Hall

woman scientist working at a machine in a lab

Supply Chain

// August 18, 2023

Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral...

Advanced manufacturing technologies like pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in manufacturing and supply chain resilience. One of the ways the U.S.

Atul Dubey

Members of Vietnam’s National Institute of Drug Quality Control (NIDQC)

Supply Chain

// August 10, 2023

Vietnam pilot project spotlights the importance of international collaboration to con...

A recently completed pilot project in Vietnam to validate and implement monitoring procedures for nitrosamine impurities in medicines is an inspiring example of how international collaboration and cooperation can help ensure medicines quality across geographies and strengthen the supply chain.

Amanda Guiraldelli Mahr Ruth Lee

Supply Chain

// August 03, 2023

Supplier qualification standard aims to strengthen supply chains for quality medicine...

USP’s supplier qualification standard became official on Aug.

Doug Podolsky