The stringency of Good Manufacturing Practices in active substance manufacturing should increase as the process proceeds from early steps to final steps, purification, and packaging….EU GMP states.
In our philosophy in order to build quality into the product with a thorough understanding of the product and process, the Quality System of the Company must embrace the whole process, starting from the earliest stages of the manufacturing activities. This is, in our opinion, a critical concept for Companies which have biological active pharmaceutical ingredients extracted from animal sources as core business products.
Gentium is proud to ensure that for each batch of drug product or drug substance manufactured, exists a robust and documented traceability chain which allows the Company, Customers or Authorities to identify up to “farm level” all the sources of which a specific batch is made.
With its revamped state-of-the-art manufacturing facility Gentium sets a new standard for the manufacturing of active ingredients extracted from biological tissues