Korea’s Minister of Food & Drug Safety: Addressing Medicines Supply Chain Resilience in the Asia-Pacific and Beyond
Building on the momentum of recent high-level enga… Read More
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Quality Matters | Blog
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Official blog of US Pharmacopeia (USP), sharing unique viewpoints on the public-health impact of worldwide efforts to promote the quality and integrity of medicines, food ingredients and dietary supplements. Writers include scientists, staff, volunteer ex
Why Standards Matter in Digital Therapeutics
Maryland, MD—United States Pharmacopeia (USP) Healthcare Quality and Safety (HQS) Center of Excellence is examining the curre… Read More
Reflecting on results from four years fighting TB in the Kyrgyz Republic
In 2022, more than 8,000 people in the Kyrgyz Republic developed tuberculosis (TB), including approxima… Read More
Advancing regional manufacturing in Africa: Four key takeaways from the 77th World Health Assembly
Expanding regional pharmaceutical manufacturing, a critical component of Afri… Read More
Biologics and biosimilars – the basics
Biologic medicines – “biologics” for short. You’ve probably seen commercials for some of them on TV. Maybe y… Read More
Public Health advocates call on policymakers to end drug shortages in the U.S.
Drug shortages pose a significant, ongoing threat to our healthcare system and to the patients w… Read More
Q&A with Mrunal Jaywant: How the Discovery of Nitrosamines in Medicines Shifted the Pharmaceutical Manufacturing Landscape
The World Health Organization (WHO) is the latest… Read More
Quality is a foundation for global vaccine preparedness
The emergence of COVID-19 almost five years ago forced us all to face the realities of containing and mitigating a highly… Read More
Building Bridges: How Collaboration is Propelling India's Pharma Industry Forward
It’s been nearly 20 years since the US Pharmacopeia (USP) established our laboratories… Read More
Procuring HIV/AIDS medicines from African producers
Expanding regional manufacturing to increase supply and improve health security across AfricaAs the U.S. President’s Em… Read More
USP’s commitment to ESG considerations for a healthier, more sustainable world
At the U.S. Pharmacopeia (USP) we recognize that fulfilling our mission to improve public he… Read More
Producing maternal health supplies in sub-Saharan Africa
Understanding the landscape to expand, strengthen, and diversify African-based manufacturing
Every two minutes, a woma… Read More
Navigating “Trending” Supplements
Last year, we witnessed growing interest in consumer health and wellness products that were trending on social media. The rise of t… Read More
Innovating for Individual Care: The Impact of USP on Personalized Medicine
In 2022, personalized medicines (PM) made up more than 34% of new therapeutics approved by the Food an… Read More
Prioritizing Quality Across the Manufacturing Eco-System in India
India is often referred to as the ‘pharmacy of the world’ and is an undeniably the leading manufact… Read More
Drivers of global health impact in 2024
Reflecting on 2023 to inform change in the New Year
Hindsight is a gift, as the saying goes, and as we close out the year, it is easy t… Read More
Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA framework: Q&A with Naiffer Romero – Part Two
Quality Matters recently sat down with… Read More
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… Read More
Q&A: Building a More Resilient Medicines Supply Chain
In this conversation, US Pharmacopeia (USP) Director of Regulatory and Public Policy Development Amy B. Cadwallader, Ph… Read More
Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA framework: Q&A with Naiffer Romero
USP’s Naiffer Romero has teamed up with researchers… Read More
Why cancer medicines are and continue to be vulnerable to drug shortages
The frightening words, “you have cancer”, will be heard by approximately 2 million people in… Read More
Mitigating Cancer Drug Shortages: USP-American Cancer Society Summit Issues Call to Action
Patient access to cancer drugs can mean the difference between life and death. Persis… Read More
Standards on the Frontlines: Responding to public health crises and strengthening supply chains
Vulnerabilities or disruptions to the global medicine supply chain (including dru… Read More
Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
(Disclaimer: The article below includes a discussion o… Read More
Beyond TB medicines: How quality assurance is elevating health systems in Central Asia
In Central Asia and Eastern Europe, multidrug-resistant tuberculosis (MDR-TB) accounts fo… Read More
Pharmaceutical Continuous Manufacturing: Regulatory landscape in the spotlight at USP workshop
The science of pharmaceutical continuous manufacturing (PCM) may not be entirely… Read More
Pharmaceutical Continuous Manufacturing: Right for some products, but not all, and hurdles abound – workshop
Pharmaceutical continuous manufacturing (PCM) is suitable for… Read More
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 recentl… Read More
Part One: Industry examining FDA guidance on nitrosamines
Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked th… Read More
Industry examining FDA guidance on nitrosamines
Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked the fifth an… Read More
Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs
Advanced manufacturing technologies like pharmaceutical continuous manufacturing… Read More
Vietnam pilot project spotlights the importance of international collaboration to control impurities and strengthen the medicines supply chain
A recently completed pilot projec… Read More
Pharmaceutical community eyeing FDA guidance on nitrosamines with great interest
Nitrosamines are naturally occurring chemical compounds that people are regularly exposed to a… Read More
Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods
USP’s supplier qualification standard became officia… Read More
Complex generics: Are global regulators addressing the needs?
The development of generic versions of innovator medicines is a global public health need. Generic medicines have… Read More
Protecting patients from substandard and falsified medicines through post-marketing surveillance
Substandard and falsified (SF) medical products remain one of the most significa… Read More
Experiences strengthening quality assurance in the APEC region
Quality assurance is a wide-ranging concept encompassing all factors that collectively influence the quality attri… Read More
Good distribution practices require coordination, collaboration, and continuous quality improvement
When it comes to good distribution practices (GDPs) for medical products, pat… Read More
Implementing regulatory reforms and investing in supply chain integrity for pandemic preparedness
Over the past three years, the COVID-19 pandemic made long-standing medical pro… Read More
Complex generics: The need and challenges
Generic medicines have benefited millions of Americans and saved trillions of dollars. Accounting for approximately 90% of prescription… Read More
Insights from India: Q&A with USP nitrosamines expert
The issue of addressing potential nitrosamine impurities in medicines has been the focus at events taking place around… Read More
Thinking differently about excipient quality to ensure medicines supply chain resilience
The quality of excipients in medicines – which make up every part of a drug other… Read More
Impurities in the medicines supply chain: Global cooperation essential to safeguarding patients
Continued global cooperation to strengthen supply chain resilience and assure med… Read More
World Vaccine Congress 2023: Spotlight shines on mRNA and viral vectored technology platforms
Interest in innovative vaccines that use messenger ribonucleic acid (mRNA) and vi… Read More
World Health Assembly: Building a medicines supply chain to meet the needs of patients everywhere
Hundreds of global public health experts converged in late May 2023 in Geneva… Read More
Internet Pharmacies are an Often-Overlooked Part of the Medicines Supply Chain
Many patients and consumers have a mental picture of the last leg of the pharmaceutical supply ch… Read More
Identifying upstream supply chain vulnerabilities can help mitigate or prevent drug shortages
After Laura Bray’s daughter was diagnosed with cancer and began chemotherapy… Read More
Manufacturing solutions are essential to strengthen the global medicines supply chain
Innovation and standardization across borders are essential to facilitate manufacturing sol… Read More
mRNA Vaccines: Your Questions Answered
Before COVID-19, most people might vaguely remember messenger RNA (mRNA) from a high school biology class; in-depth knowledge was the rea… Read More
World Standards Day: Recognizing How Standards Enable a Strong Medicines Supply Chain
Each year in October, we celebrate World Standards Day and the thousands of scientists and… Read More
