2024-04-18 16:57
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
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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
2024-03-13 13:30
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
2024-03-08 15:28
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
2024-03-01 19:45
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
2024-01-04 16:01
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
2023-12-27 17:48
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
2023-12-08 19:52
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
2023-11-27 18:57
FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards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
2023-11-27 15:45
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
2023-11-27 14:21
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
2023-10-24 17:14
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
2023-10-24 14:10
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
2023-10-10 19:06
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
2023-09-21 18:11
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
2023-09-21 12:31
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
2023-09-15 17:27
Pharmaceutical Continuous Manufacturing: Regulatory landscape in the spotlight at USP workshop
The science of pharmaceutical continuous manufacturing (PCM) may not be entirely… Read More
2023-09-15 15:57
Pharmaceutical Continuous Manufacturing: Right for some products, but not all, and hurdles abound – workshop
Pharmaceutical continuous manufacturing (PCM) is suitable for… Read More
2023-08-29 13:00
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
2023-08-23 13:09
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
2023-08-23 13:09
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
2023-08-18 15:00
Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs
Advanced manufacturing technologies like pharmaceutical continuous manufacturing… Read More
2023-08-10 13:22
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
2023-08-07 15:49
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
2023-08-03 19:43
Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods
USP’s supplier qualification standard became officia… Read More
2023-06-26 16:47
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
2023-06-21 14:53
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
2023-06-21 13:03
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
2023-06-14 12:16
Good distribution practices require coordination, collaboration, and continuous quality improvement
When it comes to good distribution practices (GDPs) for medical products, pat… Read More
2023-06-13 12:29
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
2023-06-12 12:15
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
2023-06-08 13:00
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
2023-06-06 21:00
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
2023-05-25 12:59
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
2023-05-24 19:57
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
2023-05-24 13:57
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
2023-05-23 14:25
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
2023-05-22 14:48
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
2023-05-18 14:42
Manufacturing solutions are essential to strengthen the global medicines supply chain
Innovation and standardization across borders are essential to facilitate manufacturing sol… Read More
Paradigm Shift In Drug Development: Analytical Quality By Design And Analytical Procedure Life Cycle
2023-05-17 13:41
Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle
In today’s pharmaceutical manufacturing environment, companies face i… Read More
2023-04-26 20:11
Essential elements of a strong, global medicines supply chain
The U.S. Pharmacopeia (USP) has long been recognized as an international leader in medicines quality and supply cha… Read More
2023-04-20 12:51
Standards support medicines supply chain resilience and the future of quality
It is not uncommon for people to sometimes take important things for granted, such as the quality o… Read More
2023-04-17 19:15
USP’s Preferential Access for Regulators (PAR) Program: Supporting the Global Supply of Quality Medicines
In the U.S. and around the world, quality standards developed by… Read More
2023-04-04 18:18
USP standards build trust in biologics and biosimilars
The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health… Read More
2023-03-07 18:41
Nitrosamine Impurities: Latest USP Tool Further Aids Understanding and Control
USP has launched the newest tool in our suite of solutions to address the evolving nitrosamines cr… Read More
2023-02-22 21:18
Innovative Matrix Framework Assesses Risk for Substandard Antibiotics
Substandard medicines are a huge public health threat. Proactively evaluating drug products using a relativ… Read More
2023-02-13 16:24
What’s driving drug shortages during the cold and flu season?
When shock events impact the medicines supply chain, underlying vulnerabilities can cause it to break instea… Read More
2023-02-09 18:25
Africa’s growing vaccine capacity
Manufacturing products locally for more equitable pandemic responses
Every year, vaccines prevent nearly 5 million deaths around the glo… Read More
2023-01-23 14:55
Omnibus Spending Law: Provisions Will Bolster Medicines Supply Chain Insights and Advanced Manufacturing Technologies
Investments to create a more resilient medicines supply cha… Read More
2022-12-05 15:14
How to Help Avoid Tragedies Linked to Contaminated Cough Syrup
The World Health Organization (WHO) recently issued a Medical Product Alert after four substandard products were i… Read More
2022-11-11 15:00
Latest nitrosamines recall spotlighting need to control pharmaceutical impurities
The recent announcement of a recall of two lots of the hypertension medication Quinapril and H… Read More
2022-11-10 18:01
Drug Manufacturing Innovation: Building In Quality From the Start with USP
Pharmaceutical and other healthcare innovations have extended and improved countless lives in recent d… Read More
2022-10-31 19:50
Updated Compounding Standards Help Advance Quality and Support Patient Safety
Quality should be built into the entire drug product lifecycle – including the manufacturing… Read More
2022-10-21 18:24
Choose Wisely: Quality Matters When It Comes to Recommending a Dietary Supplement
Millions of Americans take dietary supplements, including vitamins, each day. Recommendations o… Read More
2022-10-07 12:00
Tackling medicine supply shortages starting with their ingredients
How to secure upstream pharmaceutical supply chain risks with data and advanced technologies to increase acce… Read More
2022-10-06 18:58
World Standards Day: Celebrating the Role of Standards In a Strong Medicines Supply Chain
World standards day (WSD) is celebrated in October each year to recognize the thousands… Read More
2022-09-23 20:33
Storage and Transportation of Pharmaceuticals in Brazil: Overview of regulations and standards, current scenarios, and what is coming next
Proper storage and transportation of f… Read More
2022-09-23 18:30
4 Drivers of Childhood Cancer Treatment Supply Chain Vulnerability
Persistent and long-lasting shortages of childhood cancer treatments undermine the advancements in science th… Read More
2022-09-07 18:44
Monkeypox outbreak highlights supply chain complexity
Recent months have seen the emergence of monkeypox as a global public health emergency, with limited supplies of needed tr… Read More
2022-08-22 19:19
How extreme weather thousands of miles away can affect your medicines
Countries around the world continue to be impacted by record breaking climate events. Extreme weather has… Read More
2022-07-27 13:56
Adapting lessons from the COVID-19 pandemic to help ensure greater global supply chain resilience
The COVID-19 pandemic exacerbated vulnerabilities in the global medicines suppl… Read More
2022-07-11 19:41
USP Convention Series: The supply chain imperative to fight AMR by conserving today’s antimicrobials and fostering innovations
In 2019, the World Health Organization (WHO)… Read More
2022-06-23 17:42
How medicine quality affects antimicrobial resistance and the medicines supply chain
Antimicrobial resistance (AMR) occurs when microbes, such as bacteria, viruses and parasite… Read More
2022-06-22 14:23
Avoid product recalls - Know your impurities
Impurities found in pharmaceuticals are a cause for concern. By definition, impurities are any components that are not active ingred… Read More
2022-06-22 14:23
Avoid product recall - Know your impurities!
Impurities found in pharmaceuticals are a cause for concern. By definition, impurities are any components that are not active ingred… Read More
2022-06-09 17:34
Pharmaceutical continuous manufacturing: What drug makers need to know
Medicines supply chain challenges underscored by the COVID-19 pandemic have raised concerns about geograph… Read More
2022-06-07 13:31
Volunteer Spotlight: USP Beal Award winner shares perspective on making a difference for public health
This spring, long-time USP volunteer Dennis Gorecki, Ph.D., became the la… Read More
2022-05-24 14:13
Supply chain vulnerabilities exist for antimicrobial medicines: USP Medicine Supply Map analysis
Antimicrobial resistance (AMR) is named one of the top 10 global health threats… Read More
2022-05-19 13:09
Fighting maternal mortality: How standards keep new moms safe
Maternal mortality rates have continued to decline around the world in recent decades, which is news worth celebrat… Read More
2022-05-18 17:22
Geographic concentration of pharmaceutical manufacturing: USP Medicine Supply Map analysis
Since the start of the pandemic, the U.S. government has allocated over $34 billon to… Read More
2022-05-16 20:54
USP Convention Prioritizes Preparedness for a Resilient Supply Chain
An all-too-familiar experience in recent years, medicines supply chain disruptions can arise from many facto… Read More
2022-05-13 12:40
Pharmaceutical continuous manufacturing: How USP standards and related programs support quality, innovation & supply chain resilience
To help strengthen the pharmaceutical s… Read More
2022-04-21 18:40
USP volunteering in the spotlight: Tackling critical public health needs
How does a 200-year-old standards-setting institution remain an essential part of ensuring access to tru… Read More
2022-03-14 18:13
The medicines supply chain: Increasing visibility to strengthen preparedness
March 11 marked the sobering two-year anniversary of the World Health Organization’s declara… Read More
2022-03-11 15:15
Bringing together experts to advance solutions: USP Convention series on supply chain challenges
In recent months, supply chain challenges have been the subject of much media co… Read More
2022-03-08 14:35
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
2022-03-07 20:01
Bolstering capabilities to support the supply of quality medicines
Empty store shelves and media headlines have raised public awareness of the complexities, interdependencies, a… Read More
2022-02-24 19:06
Advanced manufacturing technology: Reducing barriers to adoption
Today, policymakers on Capitol Hill and other stakeholders are keenly focused on addressing vulnerabilities in t… Read More
2022-01-06 19:07
Protecting patient safety by curbing vaccine mix-up errors
by Diana Kwan, Pharm.D., USP Senior Scientist II for Healthcare Quality and Safety
Vaccine mix-ups have received natio… Read More
2022-01-03 16:01
Four global health resolutions for 2022
Reflecting on lessons from 2021 to inform global health priorities in the new year
It was one year ago this week when we welcomed news t… Read More
2021-10-13 17:07
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
2021-09-09 13:09
Best Practices in State-Level Procurement in India During the COVID-19 Pandemic: Adapting Lessons from a USP Study in Kerala
The Context
In the global race to procure vaccines… Read More
2021-08-18 17:36
USP Expands Global COVID-19 Response to Tackle Substandard & Falsified Vaccines
The challenges posed by COVID-19 transcend international borders and require global solutions… Read More
2021-05-17 14:32
Fostering Broader Access to Quality -assured COVID-19 Vaccines from Development to Distribution
The Problem
The world has not seen a global vaccine rollout and mass vaccination… Read More
2021-05-17 14:32
Fostering Broader Access to Quality-assured COVID-19 Vaccines from Development to Distribution
The Problem
The world has not seen a global vaccine rollout and mass vaccination… Read More
2021-05-05 14:55
Investing in the Last Mile First
Vaccine production at the 'last mile' could be a critical first step toward health security for Africa
By Dr. Perrer Tosso
While the global vacc… Read More
2021-05-05 14:55
Manufacturing COVID-19 vaccines in Africa
Local ‘last-mile’ vaccine production could improve health security in Africa
While the global vaccination effort to curb… Read More
2021-04-21 15:12
USP Volunteer Profile: Developing the COVID-19 Vaccine Handling Toolkit
USP’s success in its mission to improve global public health through creation of standards and rela… Read More
2021-04-01 19:32
COVID-19 Vaccine Handling: Maximizing Doses & Public Confidence
By Nurisha Wade, USP vice president, Global Healthcare Quality and Safety Center of Excellence, and Debbie Ha… Read More
2021-03-16 17:28
Quality Raw Materials & Collaboration Essential to mAb COVID-19 Treatment Access in LMICs
Access to quality raw materials and increased stakeholder collaboration are needed… Read More
2021-03-12 16:47
Nitrosamine impurities in medicines: what’s the risk?
In simple terms, risk is the possibility of something bad happening. It’s the uncertainty around the consequenc… Read More
2021-03-12 16:41
Nitrosamine Impurities in Medicines: Preventing history from repeating itself
The presence of objectionable levels of chemical impurities in pharmaceuticals can have serious pub… Read More
2021-03-11 14:41
From the Field: USP Vaccine Handling Toolkit Is Shot In The Arm For Administration Effort
USP’s recently released COVID-19 Vaccine Handling Toolkit is helping to fil… Read More
2021-02-02 21:12
Are my medicines at risk of a shortage?
Consumers in the United States often have access to a lot of information about the products they use and consume. Many products include i… Read More
2021-01-08 00:44
Ensuring quality COVID-19 vaccine delivery through the ‘last mile’
The COVID-19 pandemic has presented unprecedented challenges around the world, including to nation… Read More
2020-11-13 19:41
Breeding a superbug: how poor-quality medicines fuel AMR
Another public health crisis looms in the wake of the COVID-19 pandemic. Antimicrobial resistance (AMR) has gained incre… Read More
2020-11-02 14:26
Ignore the politics. Trust the science.
Recent politicization of the COVID-19 vaccine development and approval process has led to a concerning loss of confidence in vital govern… Read More
2020-09-17 22:25
Glycosylation in monoclonal antibody treatments for COVID-19
COVID-19 is transforming our ways of thinking about the development, manufacture and delivery of critical medicines… Read More
2020-07-30 13:01
The Role of Standards in Supporting Quality Vaccines Manufacturing and Distribution
The scale and speed of the global vaccine research and development effort in response to COVI… Read More
2020-07-09 15:19
Accelerating Development and Building Trust in COVID-19 Vaccines With Public Quality Standards Jaap Venema, Ph.D., USP Chief Science Officer
Epidemiologists are consistently as… Read More
2020-07-07 20:56
USP Convenes Global Biologics Summit to Identify Challenges to Quality Biologics Medicines
U.S. Pharmacopeia (USP) brought together preeminent thought leaders from industry, glo… Read More
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