Medicinal products differentiate from other products as quality deficiencies of medicinal products may result in serious consequences for consumers. For this reason, pharmaceutical manufacturers in Europe are subject to the Directive and a supplementary Guideline to Good Manufacturing Practice (GMP). The aim is to ensure a uniform quality of pharmaceuticals within the EU and thus to enable free movement of goods in the field of pharmaceuticals. A conversion of these regulations into German legislation is given with the Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV), which refers to the EU-GMP guideline for the interpretation of the principles mentioned there (see § 3 para. 2 AMWHV).
When applying for a manufacturing authorization, the relevant state authority checks the compliance with these regulations in an inspection. Only if these regulations are observed will the pharmaceutical manufacturer be issued a manufacturing authorization and the corresponding GMP certificate. Once the manufacturing authorization has been granted, the pharmaceutical manufacturer will be continuously inspected on site by the supervisory authority on a regular basis, every three years, to ensure that Good Manufacturing Practice is still being observed in the manufacture of medicinal products. If no objections are found in the course of this inspection, the authority issues an updated GMP certificate to “confirm the compliance of a manufacturer with GMP”.
A manufacturing authorization and with it the “GMP certificate” can only be obtained by companies for manufacturing of medicinal products, active substances and certain starting materials. Companies manufacturing other products or providing services for pharmaceutical companies regarding GMP (e.g. validations) will not be issued a manufacturing authorization or “GMP certificate”.
Are you a pharmaceutical manufacturer and need assistance in obtaining or maintaining a “GMP certificate”? Are you a manufacturer or service provider for the pharmaceutical market or do you want to serve it from scratch? Valicare GmbH offers expert advice and support to all companies in the pharmaceutical sector, including GMP and ISO compliance, supplier qualification, preparation of SOPs and protocols, qualification/validation, staff training and internal audits, including preparation for an inspection.
Dr. Ellen Sons-Brinkmann
Phone: +49 69 7909 350