Understanding the EU GMP Annex 1 Revisions

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 first of this two-part webinar series, we’ll provide an overview of Annex 1 that will include a comparison between the upcoming revision and 2008’s, as well as its place in the regulatory frameworks of other guidelines such as ICH Q9 and Q10. Other topics we’ll address include:

  • The impact of the principles of Quality Risk Management to ensure contamination prevention in the final product
  • Scope, Principle, Pharmaceutical Quality System (PQS), Utilities and Production, and specific technologies
  • Introduction and implementation of innovative technologies

Presenter

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

 

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

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