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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

Medical Device

FDA Software Guidance; Should I be worried?

FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?

CSV & Data Integrity

GAMP® 5 Guide 2nd Edition Release

Gamp 5 Version 2 released in July 2022 brings new updates for computerized systems in the Life Science industry.

Regulatory Affairs

Are you ready? Have you implemented EU ISO IDMP standards for medicinal products?

Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards

Regulatory Affairs

The EU Road to reach interoperability across regulatory systems: are you in step with the new EMA standards and regulatory systems?

The Life Science industry revolution goes along with the development of data interoperability systems that allow shared data within the entire.