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Safety & Manufacturing

Safety & Manufacturing

Commitment to Quality and Safety

We are dedicated to producing safe, effective, high-quality medicines. Each step of the manufacturing process complies with the strictest national and international product safety standards, meeting the relevant legislation or even exceeding it. Our commitment to manufacturing top quality products is well known in the industry and valued by all patient communities. We only use starting materials of the highest quality, not only for the products obtained from plasma but also for recombinant medicines. Safety and quality are also ensured by testing at various stages of the production process, as well as by several pathogen reduction steps during manufacture, the implementation of good manufacturing practice (GMP) according to the latest regulations, and by monitoring the products through pharmacovigilance.

Integrated Safety System

An integrated safety system for the production of plasma-derived products starts with the selection of donors and testing of donations. The system includes purification of the desired protein, virus inactivation and prion removal in addition to multiple levels of quality assurance, including both quality control and monitoring. The integrated safety system is comprised of the below processes:

Integrated Safety System diagram