Press Release - Ulm, 3 February 2016
Extremely strict regulations apply to the manufacturing of medicines and therapeutic agents. In order to comply with these regulations in a more efficient way than ever before, the pharmaceutical company, medac, from Hamburg has opted for the implementation of a Manufacturing Execution System in the sector of packaging. Target: An extensive software solution for the realisation of an electronic batch record according to the GMP (Good Manufacturing Practice) – including production and machine data collection as well as extensive functions for the evaluations and scheduling. After an extensive evaluation phase, the selected application was GUARDUS MES. The main aspects that influenced the decision were not only the functional spectrum, validation experience and know-how of GUARDUS Solutions AG. The software manufacturer from Ulm also convinced through its commitment. Stephan Mielke, production manager of therapeutic agents at medac GmbH, explained the decision as follows: “As a medium-sized company, we have deliberately decided against the ‘big’ software providers in the pharmaceutical field. We looked for a partner that would suit us and together with whom we could successfully master the project – and this feeling was exactly what GUARDUS-Team conveyed to us”.
In the first phase of the project, the intention of medac regarding the MES focused on the sector of the manufacturing of secondary packaging for pharmaceutical products. In the future, all the GMP-relevant processes must be documented electronically. Therefore, the Electronic Batch Record, production and machine data collection as well as scheduling and evaluations are topics on the implementation agenda. Through the MES, the company will be able to carry out the planning of production orders in a more efficient way and to assign the tasks to the employees in a more targeted way, according to their qualification. Moreover, the integration of machines, facilities and an ERP system will ensure a complete and, above all, transparent documentation of all the production processes. The objective of this exhaustive knowledge is to drastically reduce the inspection times of the electronic batch record and, consequently, to considerably improve the ‘First Time Right Quote’.
About medac
With around 1,000 employees, the pharmaceutical company medac GmbH, a corporation for special clinical preparations, located in Wedel, Tornesch and Hamburg, concentrates on the treatment and diagnosis of oncological, urological and autoimmune diseases. Nowadays, around 50 therapeutic active substances are offered in various pharmaceutical forms and packaging for the diagnosis and treatment of diseases.
