Walid El Azab
Technical Services Manager for STERIS Life Sciences
Title: EU GMP changes – impact on cleaning and process validation
Biography
Biography: Walid El Azab
Abstract
The presentation will shed light on the current European GMP changes and how these changes are now linked to each other. The presentation will also detail and explain the changes of recently effective and draft documents as the annex 15, annex 16, chapter 2, chapter 3, chapter 5 and finally the EMA guidance on setting limit. Following that, the presentation will explain the impact of these changes on cleaning, process validation and how senior management and the qualified person need to ensure compliance. In addition, the presentations will deep dive on how to assess setting limits in cleaning validation and explain the difference with the ISPE and EMA guidance. Finally, the presentation will share common questions asked by manufacturers on cleaning and process validation in Europe and what regulatory agencies are expecting to be in place.