In order to market pharmaceutical products, it is essential to provide specific information about the manufacture – e.g. of biological products – in an approval dossier and to have this approved in the form of a Biologics License Application (BLA). The dossier contains information about the manufacturing process, chemistry, pharmacology, clinical pharmacology and medical effects among other things.
Due to changed requirements, our customer, a well-known and globally active insulin manufacturer with several production sites, needed support in maintaining compliance with the BLA. Specifically, an inventory was taken on several production lines with a focus on the filtration of product solutions and the supply of raw materials and media followed by an analysis of existing concepts.
The aim of the subsequent vulnerability analysis was to develop applicable optimization proposals for all production lines and to manage the implementation of the resulting measures. The challenge here was to harmonize the measures for vulnerability optimization across the different production lines as far as possible.
Furthermore, rantronik was commissioned to promote acceptance of the implementation of the measures among the customer’s employees involved through various meetings, workshops and a series of events.
Do you also need professional support with inventory assessments and vulnerability analyses, the resulting development and the active implementation of optimization measures?
Then feel free to contact rantronik. We will be happy to advise and support you.