As an innovative pharmaceutical company, Pharma Stulln GmbH has been producing eye drops, nasal sprays and inhalation solutions for more than 30 years for its own range as well as for well-known pharmaceutical companies as a contract manufacturer. The production of pharmaceuticals complies with the German Medicinal Products Act (AMG), German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV), and the EU-GMP guidelines. The company also manufactures medical products in accordance with the German Medical Devices Act (MPG) and is accordingly certified in compliance with DIN EN ISO 13485.
The aim of this project was to ensure the cleanroom status of the aseptic production facilities by re-qualification measurements and to verify the controlled ambient conditions for the production of perfect product quality. In addition to meeting the regulatory requirements, a pragmatic and cost-sensitive approach was implemented and the integration of internal customer resources in the structuring and execution of qualification measures.
In addition to meeting the regulatory requirements, a pragmatic and cost-sensitive approach was implemented and the integration of internal customer resources in the structuring and execution of qualification measures. The result was the integrated support of the customer in the area of cleanroom, calibration and qualification of the premises in production.
