Quality Assurance/Quality Control

BIA Separations Launches AAV Process Development Service to Accelerate Gene Therapy Production

September 19, 2019

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

Quality Culture Drives Patient Confidence in Drug Products

September 15, 2019

While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.

Generics: Getting Beyond “File First, Figure it Out Later”

September 15, 2019

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

Why Pharmacopoeia Compliance Is Necessary

September 15, 2019

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.

A Brief History of Pharmacopoeias: A Global Perspective

September 15, 2019

This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.

Global Pharmacopoeia Standards: Why Harmonization is Needed

September 15, 2019

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

Harmonization Efforts by Pharmacopoeias and Regulatory Agencies

September 15, 2019

The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.

Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework

September 15, 2019

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

Global Pharmacopoeia Standards: Why Harmonization is Needed (PDF)

September 15, 2019

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework (PDF)

September 15, 2019

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.