Inside the global regulatory dialogue

September/October issue now available

IPQ and related publications will track the regulator/ industry dialogue on evolving and harmonizing the regulation of pharmaceutical and biopharmaceutical quality and manufacturing.

First two issues available for free download.

About the September/October issue

THE IMPACT OF QUALITY BY DESIGN ON BIOTECH REGULATION is growing. An FDA biotech QbD pilot and industry mock initiatives are getting underway that will build on the experience gained in the small molecule area. In the biotech context, the focus is shifting to the API and the challenges of defining critical quality attributes and design space for these complex molecules and processes. How to incorporate risk assessments and the role of “expanded change protocols” are other key regulatory filing issues. The biotech QbD pilot will leverage the growing knowledge base on comparability protocols, which are finding their way from the postapproval arena into NDAs and BLAs and influencing the IND development process. Industry associations in the U.S. and EU are also focusing on how the new QbD approaches can be applied to analytical methods to strengthen this link in the control chain.
Bill Paulson, Editor-in-Chief