After 14 years in the making, the EU GMP Annex 1 has finally been published.

Although the Annex 1 is a European guide, its impact affects every Sterile Manufacturer worldwide.

The newly released document carries many changes and improvements with it, with a special focus on two specific topics: Quality Risk Management and Contamination Control Strategy.

Watch the interview with our Annex 1 expert Giovanni Cantoni, and get in touch with us to explore how PQE Group can assist your business.

 

Do you need support implementing the Annex 1?

PQE Group staff comprises experienced and skilled experts that can support you in the goal for compliance with the new  Annex 1, in every aspect of your aseptic manufacturing: sterility assurance strategies, quality compliance, microbial monitoring, cleanroom design and revamping, equipment qualification, critical system validation, analytical methods selection and validation, and many others.
Check out Compliance Services, and contact our team to request a meeting with our experts.

 


Download Annex 1 ebook            Quality Compliance Page