Quality Matters | U.S. Pharmacopeia Blog

// 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.

Medicines

// November 28, 2023

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards ...

This year has seen a flurry of activity by the U.S. Food and Drug Administration surrounding ophthalmic products.

Desmond Hunt Margareth Marques

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

// 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 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

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

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Quality Medicines for Malaria

Global Health

// May 24, 2018

Quality Medicines for Malaria

Marie Lamy with Asia Pacific Leaders Malaria Alliance discusses how one country is tackling drug resistance in order to eradicate Malaria.

Poor quality medicines and drug resistance

Global Health

// May 24, 2018

Poor quality medicines and drug resistance

Harvard professor and physician Ashish Jha describes how poor quality medicines create the perfect opportunity for superbugs.

Quality medicines and sub-Saharan Africa

Global Health

// May 24, 2018

Quality medicines and sub-Saharan Africa

Global health advocate Mirfin Moundu talks about the dangers of poor quality medicines and how they are a threat to many Africans in treating infectious diseases and non-communicable diseases.

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Researcher holding pharmaceuticals in lab

Medicines

// November 27, 2023

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA fram...

USP’s Naiffer Romero has teamed up with researchers at LHASA Limited, AstraZeneca, Sai Life Sciences and Merck for collaborative research on nitrosamines impurities that was published this month in the Journal of Pharmaceutical Sciences. Quality Matters recently sat down with Romero, who leads USP’s Nitrosamines Exchange, to learn more about the new research and what it means for the field.

Naiffer Romero

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

Global Health

// September 21, 2023

Beyond TB medicines: How quality assurance is elevating health systems in Central Asi...

In the Kyrgyz Republic and Uzbekistan, investments in TB are resulting in broader health benefits, beyond just a single disease.

Archil Salakaia Presha Regmi

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

scientists wearing protective lab gear looking at a computer in a lab

Medicines

// August 29, 2023

Part two: Industry examining FDA guidance on nitrosamines...

This summer, a wave of regulatory activity on nitrosamines has taken place, with agencies from around the world recently publishing new or revised guidances on nitrosamines.

Mrunal Jaywant Naiffer Romero

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

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards ...

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

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

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

Building a More Resilient Medicines Supply Chain

Featured Videos

Quality Medicines for Malaria

Poor quality medicines and drug resistance

Quality medicines and sub-Saharan Africa

Discover More:

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA fram...

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

Beyond TB medicines: How quality assurance is elevating health systems in Central Asi...

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

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

Part two: Industry examining FDA guidance on nitrosamines...

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