EMA and FDA Release QbD Guidance
EMA and FDA publish joint QbD guidance on design space verification.
FDA and the European Medicines Agency (EMA) have published a second joint question-and-answer document that provides guidance on the quality-by-design (QbD) concept. The guidance focuses on design space verification and reflects the conclusions reached by European Union and US regulators.
In March 2011, FDA and EMA launched a three-year pilot program for the parallel assessment of certain quality or chemistry manufacturing and control (CMC) sections of applications that are relevant to QbD. The objective of the program is to share knowledge and harmonize implementation of the QbD concept. Experts from the Japanese Pharmaceuticals and Medical Devices Agency participate as observers in the program.
According to EMA, the pilot program is open to selected procedures, including applications for initial marketing authorizations, type-II variations, and scientific advice. Participation in the pilot program is voluntary. Interested applicants and sponsors should notify both agencies three months prior to submission of an application.
Source: European Medicines Agency
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
