ISO standard 15378 defines requirements for the internal quality management system for producers of primary pharmaceutical packaging. In addition to the active ingredient and formulation, the packaging of a drug also affects its effectiveness. Manufacturing must be performed very carefully because the packaging comes into direct contact with the pharmaceutical. “Monitored processes and production in the clean room help us keep contamination risks to a minimum,” the head of QM at Raumedic said. As a result of this vigilance, the company can provide its customers with optimal polymer packaging, Bernhard added.
In general, the industry’s good manufacturing practice (GMP) is applied in combination with a range of legal requirements. The standard draws on requirements from the German Medicinal Products Act, the German Ordinance Governing the Manufacture of Medications and Active Ingredients and regulations written by the U.S. Food and Drug Administration (FDA) that apply to pharmaceutical manufacturers.
