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Annex 1 - The Brave New World of Aseptic Regulatory ... Image 1

Annex 1 - The Brave New World of Aseptic Regulatory Compliance

Challenge from the Client

After six years in review, the final emergence of Annex 1 in August 2022 has either been a consolidation of accepted practice and wisdom, or a rude awakening for many! However, it is universally accepted that it is the greatest single change to the regulatory approach in decades. As Annex 1 deals with products made in Europe, or products intended for Europe, it is likely to have a significant international reach.

Indeed, the narrative within Annex 1 has already been adopted by PIC/S and with close ties to the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) it will undoubtedly have a global reach. The regulatory bodies have also indicated a harsh stance on the implementation date. The regulatory view emerging is that the contents of the Annex should not be a surprise at this stage. Many companies are waking up to the realization that existing facilities of a certain vintage may not comply with the new requirements. And time is running out.


Our Approach & Solution

Our approach is holistic. We don’t simply find gaps in compliance; we work alongside our clients every step of the way to provide comprehensive solutions. IPS brings a unique blend of operational expertise, regulatory exposure, and expert technical knowledge to provide real support in not just identifying gaps, but closing them.

Our team of experts developed a unique Annex 1 Gap Analysis Tool that assists in systematically analyzing all aspects of a facility, including operational processes, against the new requirements. This tool is structured to provide a single source of knowledge related to the facility’s ‘state of readiness’. Once the gaps have been identified using this tool, our team aids in the process of meeting compliance. This could include utilizing IPS resources to provide assistance with sourcing and procurement of new equipment. Our goal is to serve as a trusted advisor from start to finish.

The Results

The Annex 1 Gap Analysis Tool has been deployed to help half a dozen clients in the Americans and in Europe reach compliance. This tool, combined with our unique expertise global resources, and end-to-end support, has been extremely effective in helping our clients both address and close the gaps in compliance.


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