Latest Insights

Medical Cannabis

The peak of medical cannabis facility engineering – the “carbon negative” concept

Read the GQCan insight to find out more about Negative Emissions Structures.

Medical Cannabis

Brazilian Market – Medical Cannabis Regulatory Overview

What are the current legislative regulations regarding medical cannabis in Brazil? Read the GQCan insight to find out more about the Brazilian.

Audits

Regulatory Inspection Management during the COVID Pandemic

The Covid-19 pandemic has brought important changes in the approach to inspections by competent authorities and audits by manufacturers of their.

GxP Compliance

Do you know the 3 most important focal points of your technology transfer?

Read insight from our expert to learn more about most important aspects of technology transfer processes in the pharmaceutical landscape.

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.

Regulatory Affairs

Elemental Impurities in Veterinary Medicinal Product

In January 2023, the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products will enter into.

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