Quality Assurance

GenIbet has an experienced Quality Assurance Unit providing counselling and supporting to all aspects of GenIbet operations and functions, ensuring strict compliance with the current GMP and regulatory guidance.

The Quality Assurance department is divided in 4 main areas: Systems, Operations, Q&V, and EHS. The highly qualified team, with backgrounds as diverse as Pharmacy, Biochemistry, Biology or Engineering, has a strong knowledge on GMP requirements for Biologics and Sterile manufacturing of IMPDs.

Our robust Quality system is built upon the EMA guidelines and specifically Eudralex Volume 4, Annex 2 – Manufacturing of Biological Active Substances and Medicinal Products for Human Use and Annex 13 – Manufacture of Investigational Medicinal Products.

A dedicated QA Systems team ensures constant monitoring and improvement of GenIbet Quality System and Tools. Over the last 10 years we have had more than 30 client audits from partners such as Astrazeneca, Alexion, PPD, Merck, GSK and Novartis without any critical observation.

Our QA operations team provides close support to each and every client, being involved, together with the Project Manager, from the early project initiation until the GMP batch delivery. Post batch execution and certification support can also be provided on clients IMPD/IND submissions.

The Qualification & Validation Team assures the compliance of the equipment/facilities and computerized systems qualification/validations as well as all the daily activities inherent to those systems. This is key on the daily operations.

The EHS area manages  environmental, health, safety and sustainability topics and promote a culture of safety and environmental responsibility, ensuring that all relevant laws, regulations and standards are followed.