Addressing the Proposed EU GMP Annex 1 Changes, Your EM Program, and Micro QC Operations

Annex 1 of the EU GMP guidelines describes the European Union’s requirements for the manufacture of sterile medicinal products, including those imported from non-member nations. The latest revision, to be released in 2019, is expected to have a greater reaching impact on QA/QC and all laboratory activities.

In the finale of this two-part webinar series, we’ll break down the revised guideline to help you understand how the coming changes will affect your environmental monitoring and micro QC operations. Topics covered will include:

  • Qualification vs. routine monitoring
  • Viable and non-viable environmental and process monitoring
  • Environmental control of pharmaceutical clean rooms as the essential part of the manufacture of a quality product
  • Aseptic Process Simulation (APS)
  • Sterile medicinal product Quality Control requirements

Presenter

  • Lucia Ceresa, PhD, Senior European Product Specialist, Charles River

 

Click the link below for the other webinar in the series:

Understanding the EU GMP Annex 1 Revisions