Privatsphäre-Einstellungen

Vorbereitung der Herstellungsbereiche und GMP-Systeme vor einer FDA Pre-Approval Inspection

Dr. M. Pfeiffer und Dr. H. Scheidecker

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim a. Rh.

GMP inspections from supervising authorities play an important role for providing safe medicinal products with appropriate quality. A successful passing of these inspections influence important economic factors, e. g. the prolongation of the manufacturer’s license is dependant on a successfully passed GMP inspection. If a company wants to market one of it’s products on the most top selling market worldwide, USA, the American Food and Drug Administration, FDA, can request a so called Pre-Approval Inspection, PAI. As the mutual recognition of inspection results between the US and the European Economic Community, EEC, is currently pending [1], pharmaceutical companies which wish to market products in the US will go on facing “on site” inspections by the FDA. The success of such inspections is, beside fulfilment of cGMP requirements [2], dependent on the preparatory work within the company. This preparation should not only be restricted to the quality assurance department.
In the present publication it is described how the preparation core team, which begins it’s preparatory work approximately 1 year before the assumed inspection date, is composed, and which documents have to be prepared, and which QA systems are to be checked for “inspection readiness” and how the current inspection readiness is periodically communicated to the upper management, to keep the management duly informed about the status of the preparation [3].