| Quality Matters | U.S. Pharmacopeia Blog

Pharmaceutical Manufacturing in LMICs: Where Things Go Wrong

Patrick Lukulay Submitted by Patrick Lukulay on Tue, 05/24/2016 - 10:53
Root Causes of Substandard Medicines

In LMICs, the availability of medicines manufactured locally that do not meet quality standards is a leading cause of treatment failure and adverse events in patients and is undermining public health interventions. But where do things go wrong during pharmaceutical manufacturing in LMICs that give rise to this problem? Learn more.

Developing Quality Standards for Metal Packaging Used in Drug Products

Desmond Hunt Submitted by Desmond Hunt on Thu, 05/19/2016 - 09:20
Standards for Metal Packaging

Desmond Hunt, Ph.D., USP’s Senior Scientific Liaison, provides insight into metal packaging systems for drugs and how USP standards can support quality in this field. Dr. Hunt works closely with USP’s Expert Committee on Packaging and Distribution—the volunteer experts who serve as key decision-makers in the USP standards-setting process. Learn more.

 

Working Together to Protect Over-the-counter Medicine Quality: Microbial Testing

USP Staff Submitted by USP Staff on Thu, 05/12/2016 - 09:44
Quality of OTC Medicines

Over-the-counter (OTC) medicines, drugs available to consumers/patients without a prescription, play an important role in our modern healthcare system. An upcoming Consumer Healthcare Products Association workshop highlights how USP collaborates with key stakeholders to help address specific needs in OTC manufacturing and testing related to drug quality. Learn more.

Abandoning Quality Standards for Biologic Drugs Jeopardizes Patient Safety

Ron Piervincenzi Submitted by Ron Piervincenzi on Thu, 04/28/2016 - 14:06
Patient Confidence in Biologic Medicines

Legislation being considered by Congress will remove the requirement that all biologic medicines – drugs such as insulin, vaccines, cancer treatments and other therapies made using living matter – comply with public quality standards of the U.S. Pharmacopeia (USP). This same legislation would also apply to biosimilars. As a result, public confidence in biologics and biosimilars as well as patient safety would be at risk. Learn more.

Quality Assurance is Key to Ending Malaria—For Good

Latifa Boyce Submitted by Latifa Boyce on Mon, 04/25/2016 - 10:00
World Malaria Day

On this World Malaria Day, the world is calling for an end to malaria. We must increase efforts to ensure that antimalarials used to treat malaria are safe, effective and of good-quality. Here are some ways we can close the treatment gap and provide the millions of people newly infected with malaria each year with reliable, quality-assured medicines.

Our Concerns Regarding Congressional Proposal to Discard Public Quality and Safety Standards for Biologics

Ron Piervincenzi Submitted by Ron Piervincenzi on Thu, 04/14/2016 - 15:34
Biologics Standards Proposal

For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.

Honoring the Volunteers Who Make USP’s Mission a Reality

USP Staff Submitted by USP Staff on Wed, 04/13/2016 - 15:30
USP Thanks Its Volunteers

In celebration of National Volunteer Week, USP is proud to recognize and honor the more than 640 volunteers who serve on USP’s standards-setting and advisory bodies—the USP Council of Expert, Expert Committees and Expert Panels. These dedicated individuals help USP fulfill its mission to improve global health by readily sharing their knowledge in the continuous revision of USP’s public standards that help ensure the quality of medicines, dietary supplements and foods.

Quality Standards for Gummy Dietary Supplements Topic of Recent USP Roundtable Discussion

USP Staff Submitted by USP Staff on Fri, 04/08/2016 - 09:52
USP Roundtable on Gummy Dietary Supplements

Stakeholders representing major gummy manufacturers, ingredient manufacturers, contract laboratories, and trade associations recently participated in a USP roundtable discussion on gummy dietary supplements. They shared their views on technical and quality challenges in manufacturing as well as scientific and public health considerations related to the future development of USP quality standards for gummy dietary supplements.