| Quality Matters | U.S. Pharmacopeia Blog

Looking Ahead: Emerging Technologies and Quality Standards of Medicines

Submitted by Anonymous (not verified) on Tue, 06/05/2018 - 10:18
Emerging Technologies and Quality Standards of Medicines

USP was founded nearly 200 years ago by eleven doctors who wanted to ensure that the nation had access to quality medicines. They put together the first pharmacopeia, a book of recipes for making tinctures, extracts, and other medicines. Then, in the mid-1800s, analytical chemistry evolved to enable quality testing. Fundamentally, medicine quality is concerned with the identity, strength, purity, and performance of a product or ingredient (i.e., What is it? How much of it is there? Is there anything else present?

When is an airline a critical part of the healthcare system?

Hailu Tadeq Submitted by Hailu Tadeq on Mon, 02/26/2018 - 14:07
When is an airline a critical part of the healthcare system?

When is an airline a critical part of the healthcare system? When countries—such as Ethiopia—must import life-saving medicines.

If you ask people about what it takes to ensure medicines quality, most answers focus on how a medicine is manufactured. But there’s more to the story. The conditions under which medicines are transported and stored also have a critical role in medicines quality. This role is all the more urgent when the lives of mothers and children are at stake.

Working Toward Quality Compounded Drugs: A Critical Partnership

Jaap Venema Submitted by Jaap Venema on Tue, 01/30/2018 - 08:55
A pharmacist compounds personalized medicine.

This week Congress will hold an important and timely hearing on compounded drugs. The hearing brings stakeholders together to reflect on a law enacted nearly five years ago in response to serious public health incidents. In 2012, a nationwide fungal meningitis outbreak originating from contaminated injectable compounded sterile drugs sickened over 750 individuals and resulted in the deaths of more than 70.

Opioid Crisis: USP’s Comments to the FDA

Jaap Venema Submitted by Jaap Venema on Tue, 01/23/2018 - 12:11
Cracked opioid pill

As government agencies consider solutions to the growing opioid crisis, the Food and Drug Administration (FDA) recently sought public comment about ways to best address this national emergency. USP was pleased to provide our perspective about how public standards might help support the agency’s efforts, and to report on our recent discussions with stakeholders and the standards being considered by USP’s Healthcare Quality Expert Committee.  

Ensuring Food Safety and Authenticity

Ramona Joseph Submitted by Ramona Joseph on Tue, 01/02/2018 - 13:20
Sliced pomegranate

The threat of food fraud is a growing concern because increasingly complex global food supply chains create numerous opportunities for fraudsters. This article discusses the challenges faced by stakeholders, and how to prevent these issues before they arise. 

Compendium, compendia, compendial: Clearing up the mystery of these terms

Claudia Costabile, M.A., APR Submitted by Claudia Costab… on Wed, 11/22/2017 - 09:51
Stack of compendium

In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary. But their meaning can be a bit of a mystery to people who work outside of the pharmaceutical industry and regulatory bodies.