White Paper Sterile manufacturing and quality assurance

Discover how our Robotic Gloveless, GMP Fill & Finish for Small Batches technology is compliance with Annex 1

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This white paper provides a comprehensive overview of Annex 1, a fundamental guideline for the manufacturing of sterile products within the pharmaceutical industry. It discusses the key requirements, best practices, and implications for pharmaceutical companies, emphasizing on the importance of control contamination strategy , quality risk management, and data management for quality assurance. It emphasizes the importance of adhering to Annex 1 requirements to ensure the highest standards of quality and safety.

The white paper also provides a comparative analysis between Annex 1 08 and Annex 1 22, highlighting the key differences between the two revisions, and presenting the most remarkable changes and updates that Annex 1 22 brings. In addition, the white paper discusses the obstacles faced by CDMOs in adapting to Annex 1 requirements. These obstacles include upgrading facility infrastructure, implementing new processes and procedures, managing data overload, and personnel training.

It also demonstrates how White Raven is fully adherent to Annex 1 guidelines, by checking all the Annex 1 requirements from control contamination strategy, to quality risk management, passing by the state-of-the-art machinery.

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