New EU GMP Annex 1: The Beginning of a New Era

Why it is important to improve your QC manufacturing processes

The long-awaited final version of Annex 1 was released in August, launching a new era for the industry.

What happens now?

The 58-page document gives us an opportunity to implement modern QC solutions that emphasize innovative and advanced technologies that will allow Pharma companies to speed up their processes. These advances will also help to reduced human error and ensure their final products are protected from microbial, particulate and pyrogen contamination, and most importantly, safe for patients.

The requirements that may make an impact on your organization are:

• Pharmaceutical Quality Systems (PQS), which includes the principles of Quality Risk Management (QRM) into sterile drug manufacturing
• A holistic approach to the Contamination Control Strategy (CCS) and a documented plan to keep your manufacturing environment under control
• Aseptic Processing: Approach to contamination control can be extended to other products that are not intended to be sterile such as certain liquids, creams, ointments, and low bioburden biological intermediates

Microbial Solutions | Charles River has always underlined the importance of a robust QRM and CCS and our full portfolio of QC products and services is ready to support you implement changes to be compliant with the new requirements of the 2022 version of the Annex 1.

If you are new to the industry and would like to follow the long journey of this final version of the EU GMP Annex 1, feel free to watch our video series and review this article where our Subject Matter Expert, Lucia Ceresa, provides more guidance on this regulation.