The new EU GMP Annex 1, which came into effect on the 25th of August 2023 is a step further in the regulation of sterile manufacturing which introduces several key advancements and requirements to sterile manufacturing, differentiating it from the earlier version of the document.
The new Annex 1 guidelines align perfectly with ICH Q9 and Q10 principles on critical issues such as quality systems and pharmaceutical development and take a holistic, science and fact based approach to proactive risk identification, modern equipment design, and robust control systems to ensure product sterility. In addition to these noticeable changes, the revised document adopts modern advanced concepts including Quality Risk Management (QRM), Contamination Control Strategies (CCS), and modern barrier technologies which introduce new requirements for pharmaceutical manufacturers.
The comprehensive revision, now in effect, which is in the form of a 59-page document, is undisputedly a significant upgrade from the previous Annex, which has not received a major overhaul in over a decade. This major upgrade means pharmaceutical manufacturers now have to familiarize themselves with all the changes in Annex 1 to know what is required of them not just as a means to attain and maintain regulatory compliance to ensure the continued production of safe, high-quality sterile products, but to gain an edge and stay ahead in the industry.
Our upcoming live webinar will break down these changes and highlight their impact on sterile medicinal product manufacturing, not just in Europe, but in other parts of the world as well so it is definitely worth every second if you want to stay ahead of the curve in an ever-changing regulatory landscape.