Contract manufacturer SternMaid has passed the GMP audit for pharmaceutical producers, which is conducted every three years by the German regulatory authority. Recertification confirms that the company continues to follow the rules of Good Manufacturing Practice for sensitive pharmaceutical blending and filling orders as set out in Part II of the EU GMP Guidelines and officially confirms a “very well functioning” system of quality management, the company says.
One section of the Wittenburg production plant is geared to the needs of the pharmaceutical industry. The central features include a qualified container blending line in which all the parts were designed and validated according to pharmaceutical standards, and packaging lines for boxes, drums or big bags (FIBCs).
At this facility, the company manufactures pharmaceutical excipients, nutritional supplements and balanced dietetic products in accordance with the GMP guidelines. Production takes place in a separate complex of buildings with separate rooms for palletising, weighing, handling of raw materials, blending and filling. The complex is classified as a special hygiene zone and supplied with filtered and conditioned air, while a validated cleaning procedure is aimed to provide the highest possible standard of hygiene and safety.
Mark Riemer, a member of the management board of SternMaid, said: “We have our processes and standards checked regularly in the form of internal and external audits. Besides ensuring consistent quality, this permits continuous optimisation and guarantees that new requirements are met directly. With this GMP recertification we are optimally equipped to do justice to products for which extremely strict hygiene regulations apply.”
