In April 2010, Haupt Pharma Amareg inaugurated several new purpose-built laboratories for pharmaceutical development, and in so doing increased its capacity for analytical development projects.
These new laboratories are designed specifically to optimise the workflow of development tasks, avoiding the need to share resources with routine investigations. Thus, the need to schedule development activities is eliminated from the routine analysis agenda. Coordination processes in both departments are rendered considerably simpler.
At Haupt Pharma Amareg, development analysis is responsible for the development and validation of analytical methods. It deals primarily with solid-based formulations, particularly cytostatics. The department is furthermore responsible for approvals of clinical trial supplies. In addition, it carries out analysis related to the definition of new in-house analytical methods. Method validations of this kind are required upon the request of a customer to transfer the production and testing of their products without existing methods to Haupt Pharma Amareg. Previously, approximately 20 to 30 new bulk products have been validated annually.
Consequently, in future the analytical activities of the development department will be separate in terms of both organisation and facilities from the routine investigations that are carried out for quality control purposes; this will enable analysis of both kinds to be planned and conducted even more efficiently within the site.
To find out more about the services offered by Haupt Pharma Group, please visit Haupt Pharma’s website.