The frequency at which alarms are assessed should be based on their criticality while the process and equipment should be evaluated for trends.
In January 2023, the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products will enter into.
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
FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?
Gamp 5 Version 2 released in July 2022 brings new updates for computerized systems in the Life Science industry.
Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards
The Life Science industry revolution goes along with the development of data interoperability systems that allow shared data within the entire.
