PREPARING FOR THE ANNEX 1 REVISION: A H LISTIC APPROACH TO CONTAMINATI O N CONTROL

Catherine Jomary, Ph.D., ATMP Technical Lead at Integrated Project Services (IPS), reframes the understanding of contamination control under the EU GMP Annex 1 regulatory revision, which takes e ect in August 2023, to fully encompass the human and technological processes involved in the interconnected nature of modern pharmaceutical manufacturing.

Author: CATHERINE JOMARY ATMP Technical Lead,

As we prepare for Annex 1 to take effect, it is important to understand the big picture and recognise the benefits of this regulatory revision. I tell clients that, in many ways, this is an excellent tool for us. Previously, the regulatory strategy of GMP (good manufacturing practices) was deliberately vague and open for interpretation which allowed the industry to excuse certain practices as “good enough.” In terms of contamination control, “good enough” seemed to achieve good customer safety results. Over time, the nature of the pharmaceutical product required more attention to contamination control. In this age of cell and gene therapy (or Advanced Therapeutic Medical Products, as they are commonly known outside of the US), the call for purity in our products is even more critical because the consequences of failing to act are more dire.

Annex 1 is built on mitigating risk. It is a compilation of the best contamination control practices currently in operation in facilities across the globe. Since the release of the first drafted Annex 1 revisions, I have worked with clients across the industry to understand how these regulations might impact their operations.

Annex 1 calls for a holistic understanding of the manufacturing process. Under Annex 1 regulations, we must thoroughly understand the relative risks involved in introducing contamination into any aspect of our facilities, from the flow of raw materials and personnel throughout the facility to air handling, the cleaning of manufacturing surfaces, and the egress of waste materials. Nothing is left to interpretation, and everything must be accounted for in your risk-assessment analysis.

This analysis extends to every corridor and every room across the facility. It impacts the worker experience from the moment they enter the building.

WHAT DOES IT REALLY MEAN TO HOLISTICALLY ASSESS YOUR FACILITY?

It is important to read the Annex 1 revisions and understand what is being asked of the industry. Many companies often skim these revisions and believe that they are already compliant, and no changes will be needed before August. Many often fail to realise the inherent risk of that line of thinking. It all returns to the notion of a holistic approach to understanding risk across the facility. Without a thorough facility audit regarding Annex 1, you simply do not know what process needs to be reconfigured to come into compliance or what technological changes need to be incorporated

Follow us here!

Your Thermal Packaging Specialist