Addressing the Proposed EU GMP Annex 1 Changes, Your EM Program and Micro QC Operations
: 30 Oct 2018
Sector: Clinical, Pharmaceutical
Type: Training, Webinar
Overview 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,
Click the link below for the other webinar in the series: