August 2025 marks two years since revisions to Annex 1 of the European Union’s Good Manufacturing Practice (GMP) guidelines were introduced. Niamh Bissett, director, business transformation at West Pharmaceutical Services discusses.
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Having been in development for several years, the updated guidance was widely anticipated to launch the start of a new era in the sterile manufacture of parenteral products, not just in Europe but across the world. It effectively raised the bar for companies across the pharmaceutical supply chain, challenging the sector to deliver enhanced levels of public health protection by meeting new quality benchmarks in the production and packaging of sterile medicinal products.
As has been well documented, a key focus of the revised EU GMP Annex 1 is the requirement to implement a Contamination Control Strategy (CCS) to safeguard against the patient risks associated with compromised drug integrity. Regulators endorsed the adoption of a holistic approach to CCS, with the need for all components and processes to contribute to secure, sterile containment. In manufacturing environments, the guidance specifically includes the recommended use of Restricted Access Barrier Systems (RABS) and isolators, while packaging components must evidence the performance of the Container Closure System.
The extensive list of requirements set out in the revised EU GMP Annex 1, when considered as a whole, has left pharmaceutical manufacturers grappling with an onerous challenge. While none would contest the objective of enhancing patient safety, working towards compliance has not necessarily been straightforward, requiring not only investment in physical equipment but also in time and resources.
Implementation has been further complicated by a perceived lack of clarity over certain elements of EU GMP Annex 1 and whether they would be deemed advisable or obligatory in the harsh light of an inspection. As such, many companies have been caught in a conundrum between whether they immediately adopt a best-practice strategy across the board or whether they look to meet compliance thresholds by adopting a more tactical approach to enhancing contamination control. Others, confused by how to interpret the guidelines, have simply been left wondering ‘where should I start?’
It is an understandable position of course, as any change inevitably brings with it unease and confusion. At West, we are working with our pharma partners to help uncover the vital answers they need as they work towards EU GMP Annex 1 compliance through our understanding EU GMP Annex 1 from a supplier perspective. As key stakeholders in the supply chain, suppliers play an integral role in delivering an effective CCS because of the interactive and interlinked nature of the processes involved. We have opted to mirror the requirements facing industry partners in our own internal operations, providing us with a deep understanding of EU GMP Annex 1 and putting in place a data-driven model that ensures ongoing compliance through continuous improvement. This ensures we are in step with our pharma partners with both parties having a robust approach to contamination control.
As part of our process, we identified four key areas of consideration for EU GMP Annex 1 readiness that are as equally applicable to us as a supplier as they are to pharmaceutical manufacturers: people, communication, process and continuous improvement.
As with any transformation, people are key to implementing change effectively. This led to us defining and establishing a multidisciplinary team to oversee the implementation of our CCS strategy. This centralised approach provides crucial leadership and direction while at the same time, supporting the effective dissemination of consistent messaging across the wider organisation.
Continued, consistent and coherent communication is essential for maintaining engagement and focus among West team members, and our goal has been to create a Community of Practice (CoP), where all stakeholders are clearly aligned on the collective ambition to enhance contamination control measures. Individuals understand they have a personal responsibility to contribute to the collective effort, and we are actively encouraging an open culture of information-sharing through the simple, yet effective, mantra of ‘See-Do-Say’.
As is the case for our pharmaceutical partners, implementing process-improvement measures can be challenging across a global business with diversified areas of operation. For this reason, West’s approach to compliance with EU GMP Annex 1 integrates global thinking with local delivery. Based on our understanding of the requirements, we performed a gap analysis on manufacturing controls at local sites and across the enterprise. We then developed and approved a master CCS, which was implemented as an Enterprise Standard Operating Procedure (ESOP). This has been vital in providing local teams with a centralised framework for creating site-specific contamination control plans that address previously identified areas for improvement, bringing everything in line with a unified system of controls that cover all aspects of manufacturing, from equipment and environment to processes and personnel.
From these standardised foundations, we look ahead to a future underpinned by continuous improvement. We can now evaluate the data being continuously accrued in our knowledge management systems, comparing it against internal and external benchmarks to gain valuable insights into areas where further iterations and enhancements can be made. This ‘forever’ lifecycle approach facilitates the constant evolution of process controls to deliver ongoing improvement over time in a sustainable way.
Crucially, the developments we have made in the area of CCS ensure that, as a trusted supplier, our products and services can dovetail comparatively seamlessly into a pharmaceutical manufacturer’s own approach to EU GMP Annex 1 compliance. From the additional requirements in supporting documentation to strategies for supply and logistics, we understand how to form part of an integrated, collective approach to contamination control. For partners, that not only provides the expected assurances of product quality but also helps ease the burden of adjusting to the exacting demands of EU GMP Annex 1 by themselves.
On reflection, 25 August 2023 was never going to trigger an overnight change in the sterile manufacture of parenteral drug products, akin to the flick of a switch. It did, however, mark the important transition to a new era, and our learnings have shown how, through an open-minded culture, adaptation and investment, supply-chain stakeholders can approach this era with confidence as they continue to enhance patient safety and better support pharma partners far into the future.