Curia Global, Inc. (Curia) has announced a significant $4 million investment aimed at upgrading its aseptic manufacturing capabilities in Valladolid, Spain. This strategic enhancement aligns with the latest EU GMP Annex 1 standards, underscoring Curia’s commitment to regulatory excellence and product quality. The Annex provides essential guidance for the design and control of facilities and procedures used in sterile product manufacturing, emphasizing Quality Risk Management (QRM) principles to mitigate contamination risks.
The investment will facilitate crucial upgrades to the site’s infrastructure and technology, primarily focusing on modernizing equipment and transitioning to a fully closed system. This includes the installation of new isolators and improvements to HVAC systems, automation, and utilities, all designed to enhance process safety and operational efficiency. Additionally, ergonomic enhancements for operators and stricter data integrity measures are being implemented to ensure compliance with 21 CFR Part 11.
Philip Macnabb, CEO of Curia, emphasized the importance of quality and compliance in their operations, stating that these upgrades will bolster customer confidence in their ability to deliver high-quality sterile APIs at scale. The investment not only positions Curia to handle increasingly complex manufacturing projects but also reflects a broader company-wide evaluation aimed at optimizing operations across its global network. With over 20 years of experience in API aseptic processing, Curia is committed to delivering life-changing medicines with unwavering quality and reliability.
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