The MES system (Manufacturing Execution System) for galenic development enables GMP-compliant documentation of developmental and clinical sample approaches in the development department for parenterals (medication that is administered without passing through the gastrointestinal tract). Galenic development is concerned with the form of a finished drug made up of one or more active ingredients and one or more excipients.
Supplement
The standard PMX MES product from Propack Data (Rockwell Automation) is adjusted to the specific requirements in a development department. The software is based on a core system that forms the basis for rollouts to other production and development sites in the pharmaceutical group. In the first stage, an interface is implemented with the production department's MES system at the same site. In a later stage, a connection to mySAP ERP is created.
Subject description
The manufacturing execution systems (MES) on the system are designed specifically for production processes. These systems are not as suitable in the less stringent application in pharmaceutical development, where goods are also given the quarantine status for trial purposes, for example. The group's MES core is expanded accordingly in a global project and, on this basis, a special MES is rolled out for the development department in Germany, under the local PTA project management. In a later stage of the project, an additional development site in Switzerland is integrated into the system.