Medicinal products differentiate from other products as quality deficiencies of medicinal products may result in serious consequences for consumers. Therefore, guidelines for Good Manufacturing Practice (GMP) are obligatory for pharmaceutical manufacturers in Europe. But what does a GMP certificate mean and who can obtain it?
The GMP-guidelines are translated into country-specific legislation, and for this reason, compliance of those guidelines is ensured by competent supervisory authorities of respective countries.Supervisory authorities execute GMP inspections at pharmaceutical manufacturers and grant a manufacturing authorization, a colloquial “GMP certificate”, if compliance of guidelines is ensured. Furthermore, after conferral of the manufacturing authorization, pharmaceutical manufacturers are inspected on a regular basis every two years by supervisory authorities and are monitored to guarantee GMP compliance of the production of pharmaceuticals continuously. If pharmaceutical manufacturers comply with GMP guidelines, supervisory authorities issue a “confirmation of GMP compliance of the manufacturer” and therefore renew the “GMP certificate”.
Manufacturing authorization and with it the “GMP certificate” can only be obtained for manufacturing of medicinal products, active substances, certain starting materials and excipients. Companies manufacturing other products or providing services for pharmaceutical companies regarding GMP (e.g. validations) won’t get a manufacturing authorization (“GMP certificate”).
You are a pharmaceutical manufacturer and need support to get or renew a „GMP certificate“? You are manufacturer or service provider for the pharmaceuticals industry or want to entry into the market? Valicare GmbH offers competent consultation and support to all companies in the pharmaceutical sector regarding GMP and ISO compliance, qualification of suppliers, generation of SOPs, protocols and white papers, qualification/validation and internal audits.
Dr. Ellen Sons-Brinkmann
Phone: +49 69 7909 350