Latest Insights

Annex I

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 I

Interview with Annex 1 Expert - Giovanna Cantoni

Watch the interview with PQE Group Annex 1 Expert Giovanna Cantoni

Annex I

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 I

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 I

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 I

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 I

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.

Annex I

New EU GMP Annex 1 – Implications for QRM application

Learn more about the new requirements, recommendations and detailed specifications included in the new Annex 1 and the implications for QRM.