EU GMP Annex 1 Volume 4: Laying Supply Chain Foundations That Bring Confidence to Compliance

Annex 1 of the European Union’s Good Manufacturing Practice guidelines (EU GMP Annex 1) has loomed large over the manufacture of parenteral products since it was first introduced in August 2022.

By raising the bar for companies across the pharmaceutical supply chain − not just in Europe, but across the world − EU GMP Annex 1 was expected to trigger a wholesale shift in the production and packaging of sterile medicinal products with a view to enhancing levels of public health protection.¹

And while the industry has undoubtedly seen much evidence of change since the guidelines officially came into effect two years ago on August 25, 2023, implementation has not necessarily been straightforward. For many manufacturers, the path to compliance has offered up complex challenges, requiring not only investment in physical equipment but also in time and resources. The overarching objective might have been clear, but many questions have arisen over how to formulate a clear strategy that prioritises tasks in an optimal approach.

As a key partner to the pharmaceutical industry, West has long recognised the significance of EU GMP Annex 1 and the fact that its impact is felt throughout the entire supply chain. We understand that, while the responsibility for compliance ultimately sits with the finished product (drug/biologic) manufacturer, compliance requires contributions from all stakeholders, particularly in relation to the adoption of an effective Contamination Control Strategy (CCS). As such, West has undertaken internal measures to fully align our organisation with EU GMP Annex 1 benchmarks. This means we are better-placed to support partners in their own compliance efforts, not only through the supply of high-quality ready-to-use parenteral drug packaging components and systems, but also in terms of the expertise and guidance from our knowledgeable team.

To achieve the objective of internal compliance with EU GMP Annex 1, we set our targets on meeting the same expectations and standards faced by industry partners. This precipitated a re-engineering of various systems and processes, while at the same time equipping us with a deep understanding of the guidelines and the demands relating to contamination control. Our efforts were guided by a comprehensive plan that focused on the four key pillars of people, communication, process and continuous improvement.

People are always at the heart of effective transformation, and at every stage of our EU GMP Annex 1 journey we have been mindful to engage, inform and encourage West colleagues. Early on, we defined and assembled a centralised multidisciplinary team to own and oversee implementation of our CCS strategy. This was crucial to provide leadership and direction, and to co-ordinate the dissemination of coherent and consistent messaging across the organization.

Relevant members of staff were then welcomed into a Community of Practice (CoP), which provided a platform to facilitate sharing of information, learnings and best practice on an ongoing basis. This structure also served to underline the notion that West’s ambition to enhance contamination control measures is reliant on every individual accepting their own responsibility to contribute to the collective effort of enhancement and improvement. This was encouraged through the simple, effective and empowering mantra of ‘See-Do-Say’.

Naturally, challenges are likely to arise when implementing cultural change and process-improvement measures across an international business with diversified areas of operation. To address this, West’s approach balanced global thinking with local delivery, with our gap analysis for meeting EU GMP Annex 1 requirements considering manufacturing controls at both an enterprise and local site level. We then developed and approved a master CCS, which was implemented as an Enterprise Standard Operating Procedure (ESOP), creating a centralised point of reference for the implementation of localised contamination control plans covering all aspects of manufacturing, from equipment and environment to processes and personnel.

Beyond implementation, detailed consideration was given to continuous improvement. All data accrued in our knowledge management systems can be compared against internal and external benchmarks to isolate where further iterations and enhancements can be made, with a commitment to the constant evolution of process controls over time as part of a ‘forever’ lifecycle approach.

For West, addressing the challenges of EU GMP Annex 1 compliance through these four filters of people, communication, process and continuous improvement has provided us with a coherent, integrated and impactful approach to enhancing contamination control. Crucially, however, we are able to bring the benefits of this approach to pharmaceutical partners, knowing that our processes, products and services can dovetail comparatively seamlessly into their own approach to EU GMP Annex 1 compliance. From additional requirements in supporting documentation to strategies for supply and logistics, because we understand what the guidelines require, we are able can bring clarity and direction in the face of multifaceted, complex demands to limit contamination risk.

Reflecting on the past two years, the transition to EU GMP Annex 1 appears to have been more evolution than revolution, with points of friction holding back plans and hindering progress. With the support of a well-prepared supply-chain partner such as West, however, manufacturers can be confident in their compliance efforts, and rest assured they are taking the most rigorous approach to contamination control in the manufacture of sterile medicinal products.

¹ https://www.gmp-compliance.org/files/guidemgr/20220825_gmp-an1_en_0.pdf