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In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.
EU GMP Annex 1 is a regulatory guideline issued by the European Union to govern the manufacture of sterile medicinal products. Originally published in August 2022 and legally binding as of August 25, 2023, it applies to all manufacturers supplying sterile injectables into the EU, regardless of geographic location. Its primary goal is to enhance public health protection by enforcing stricter contamination control measures across the pharmaceutical supply chain. The regulation emphasizes a risk-based approach and requires manufacturers to implement a comprehensive Contamination Control Strategy (CCS).
The finished product manufacturer—whether producing drugs or biologics—is ultimately responsible for ensuring compliance with Annex 1. However, successful implementation requires collaboration across the supply chain. Suppliers like West play a critical role by providing compliant components, documentation, and support services. This shared responsibility ensures that contamination control measures are embedded throughout the product lifecycle.
Compliance with the revised Annex 1 presents several challenges, including the need for investment in new equipment, infrastructure upgrades, and allocation of time and resources. Companies must also navigate cultural and operational changes across global sites. Strategic planning is essential to prioritize tasks and ensure that contamination control measures are effectively integrated into existing processes.
West has adopted a four-pillar approach to Annex 1 compliance: People, Communication, Process, and Continuous Improvement. A multidisciplinary team was formed to lead implementation, supported by a Community of Practice (CoP) to share best practices. Consistent messaging across the organization ensures alignment, while a master CCS was developed and implemented as an Enterprise SOP. Continuous improvement is driven by benchmarking and data analysis to refine contamination control strategies over time.
West’s CCS is a centralized framework that guides local site-level contamination control plans. It encompasses equipment, environment, processes, and personnel, and is embedded into operations via an Enterprise Standard Operating Procedure (SOP). The CCS ensures that contamination risks are identified, assessed, and mitigated consistently across all manufacturing sites.
West’s internal alignment with Annex 1 enables it to support pharmaceutical partners with products and services that meet regulatory expectations. This includes compliant packaging components, supporting documentation, and logistics strategies. Partners benefit from West’s expertise and clarity in navigating complex contamination control requirements, enhancing their own compliance efforts.
No. Annex 1 compliance is an ongoing process. West treats it as a continuous lifecycle, with a commitment to evolving process controls over time. This approach ensures long-term alignment with regulatory expectations and industry best practices, fostering a culture of continuous improvement.
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.
Want to learn more? Click to access the other Annex 1 FAQs in our blog series.
To speak with an Annex 1 expert, click here
If you would like to learn more about meeting EU GMP Annex 1 requirements, click here
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