Latest Insights

Annex 1

Applying Regulation (EU) no. 536/2014 in Clinical Trials

Europe has implemented the new Clinical Trials evaluation system, fully applying Regulation (EU) no. 536/2014. Are you aware of the changes?

Annex 1

Alarms: Can they be considered as batch release parameters?

The frequency at which alarms are assessed should be based on their criticality while the process and equipment should be evaluated for trends.

Annex 1

From Reasoning to Specifics: New GMP EU Appendix 1

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

Annex 1 Quality & Compliance August 2022 Update

Annex 1 was finally released in August 2022. It is time to consider the impact of these requirements on your own enterprise and organization.

Annex 1

Interview with Annex 1 Expert - Giovanna Cantoni

Watch the interview with PQE Group Annex 1 Expert Giovanna Cantoni

Annex 1

New EU GMP Annex 1 & Sterility Assurance Barrier Technologies vs. Quality Management

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

Annex 1

The new EU GMP Annex 1 - Environmental Monitoring Sampling Zones

How does the Annex I shape the Environmental Monitoring strategy in your sterile facility?

Annex 1

New EU GMP Vol.4 Annex I and Environmental Monitoring leverage

Learn more about new steps to improve your Enviromental Monitoring plan and where they can lead your cleanroom strategy and contamination control.

Annex 1

2020 Annex 1 draft: new challenges for sterile manufacturers

The new Annex 1 is a milestone standard for all sterile manufacturers, with important insights and implementations for the sterility assurance of the.

Annex 1

Critical Utilities GMP Compliance and new Annex 1

Find out about the new Annex 1 and the role of Critical Utilities in a wider-context Contamination Control Strategy.