Navigating the new realities of Annex 1 in sterile pharmaceutical manufacturing is crucial for compliance.
The Contamination Control Strategy plays a vital role in the framework of the revised EU GMP Annex 1, encompassing critical control points and.
Europe has implemented the new Clinical Trials evaluation system, fully applying Regulation (EU) no. 536/2014. Are you aware of the changes?
The frequency at which alarms are assessed should be based on their criticality while the process and equipment should be evaluated for trends.
The updated GMP EU Appendix 1 finally came about in August 2022. Its application is the fundamental backbone for manufacturers of medicinal products.
Annex 1 was finally released in August 2022. It is time to consider the impact of these requirements on your own enterprise and organization.
Watch the interview with PQE Group Annex 1 Expert Giovanna Cantoni
Product contamination is one of the topics addressed in the new EU GMP Annex I, our expert Alessio Rosati explores the topic on our blog
How does the Annex I shape the Environmental Monitoring strategy in your sterile facility?
Learn more about new steps to improve your Enviromental Monitoring plan and where they can lead your cleanroom strategy and contamination control.
