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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.
Contamination control is a central theme in the revised EU GMP Annex 1, which aims to enhance the production and packaging of sterile medicinal products. It ensures that all aspects of manufacturing are optimized to minimize or eliminate contamination risks, thereby safeguarding public health and product integrity.
The CCS requires a holistic and integrated approach across multiple domains—personnel, equipment, facilities, suppliers, and environmental controls. Manufacturers must align complex processes and behaviors to meet stringent regulatory expectations, which demands significant operational and cultural transformation.
West has embedded contamination control across its operations through a comprehensive strategy focused on four pillars: people, communication, process, and continuous improvement. This alignment ensures that West’s manufacturing practices meet the same regulatory standards expected of its pharmaceutical partners.
West acts as a strategic supply-chain partner, offering best-practice support and insights gained from its own compliance journey. By sharing its framework and expertise, West helps partners strengthen their CCS and improve contamination control outcomes.
A holistic CCS integrates all interconnected manufacturing processes into a unified roadmap. It aims to optimize controls across every area—from raw material handling to final product release—ensuring consistent quality and minimizing contamination risks throughout the production lifecycle.
Yes. In the production of elastomer vial stoppers, controls are applied at every stage: raw material inspection, mixing, molding, coating, trimming, and final release testing. For cleanroom applications, steam sterilization may also be included. This illustrates the depth and breadth of controls required for effective contamination management.
West’s strategy includes: (1) Foundation Phase – focusing on stabilization and standardization, including behavior training and harmonized procedures; (2) Data Analytics Phase – leveraging digitized monitoring to identify gaps and trends; and (3) Integration Phase – aligning knowledge systems and risk management to drive continuous improvement and aim for zero defects.
Data analytics enables real-time monitoring and historical trend analysis, helping identify weaknesses and predict future risks. This empowers organizations to make informed decisions and prioritize contamination control efforts effectively.
The final phase integrates knowledge systems with risk management, supported by skilled personnel and automation. It emphasizes consistency, Quality by Design, and continuous improvement, aiming to target zero defects and elevate standards across materials, processes, and facilities.
West’s transparent and strategic framework provides manufacturers with confidence in their supply partner’s capabilities. It supports the delivery of sterile medicinal products that comply with EU GMP Annex 1, ultimately benefiting patients who rely on safe and effective treatments.
The successful transition to this final stage is more the product of evolution than revolution. It reflects the fact that EU GMP Annex 1 has demanded a complex and fundamental re-engineering of approaches to contamination control, in terms of operations, processes and systems as well as mindset and behaviours.
West’s own deep understanding of that challenge provides pharmaceutical manufacturers with the assurance of working with a trusted supply partner to enable the delivery of sterile medicinal products that are compliant with EU GMP Annex 1. Our clear framework and transparent approach to best-practice provides a strategically effective approach to implementing an effective contamination control strategy – for our own business, for our partners, and for patients reliant on sterile medicinal products for essential disease treatment.
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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