Annex 1 is part of the EU GMP guidelines. The revised EU Annex 1 came into effect in August 2023. It defines requirements for the manufacturing of sterile medicinal products with the goal of minimizing contamination risks and ensuring maximum patient safety. A Contamination Control Strategy (CCS) serves as the foundation for all processes, aiming to identify and mitigate potential risks. Cleanroom classification, barrier technologies such as isolators and RABS, and validated sterilization methods are essential to achieving compliance. Continuous environmental monitoring ensures sterility. Annex 1 applies to all manufacturers of sterile medicinal products in the EU, as well as exporters to the EU.
Talk to an expert Your challangeRegulation for the manufacture of sterile medicinal products
Expansion from originally 16 to now 58 pages
Preventing product contamination
A wide range of innovative technologies help you master key production challenges. Whether it’s new acquisitions, modernization, process optimization to prevent contamination, or risk management – we offer carefully planned, field-tested solutions.
We support you in implementing continuous monitoring and documentation processes, ensuring data integrity in monitoring systems, as well as validation-compliant documentation and qualification. With solutions for real-time particle monitoring systems (e.g., BioTrak), we ensure efficient and compliant processes.
Isolator technologies, RABS systems, and digital monitoring solutions enhance safety and efficiency in the production process. Our fully integrated solutions, including turnkey isolators and CSPE approaches, cover everything from flow optimization to fully integrated Factory Acceptance Testing (FAT) for maximum safety. Additionally, the intelligent use of robotics – leveraging software and automation, including AI – reduces glove interventions.
The validation and qualification of cleaning and disinfection processes are essential for safe production workflows. We offer solutions such as PUPSIT (Pre-Use Post-Sterilization Integrity Test), effective sterilization methods for freeze dryers, and automated loading and unloading systems to optimize efficiency and compliance.
Annex 1 defines the strict standards for the manufacture of sterile medicinal products – and with Optima as your partner, you benefit from decades of expertise and state-of-the-art technology to help you meet the highest quality requirements.
Gerne senden wir Ihnen das Whitepaper zu Annex 1 zu. Sie erhalten eine E-Mail mit einem Download-Link.
Would you like to optimize your processes in compliance with Annex 1 and learn more about our expertise? We are happy to share our knowledge with you. Download our free whitepaper “Name” to gain valuable insights into our solutions and real-world experience.
Why OPTIMA?
Tailored Annex 1 solutions and support from concept to operation and beyond: With extensive practical experience, innovative technologies, and a holistic approach, we help you optimize your production processes—individually, efficiently, and with a focus on the bigger picture. For maximum safety in the manufacturing of your pharmaceutical products.
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