GMP-Selbstinspektionen als Vorbereitungs-Tool auf Kunden und Behörden-Audits Vorstellung einer Möglichkeit der quantitativen Darstellung von Audit-Ergebnissen Dr. Michael Pfeiffer GFB Pharma-Herstellung, Abteilung Quality Operations, Boehringer Ingelheim, Pharma GmbH & Co. KG, Ingelheim/Rhein GMP self-inspections play an important role within the entire quality assurance system of a pharmaceutical manufacturer. According to the EEC Guide to Good Manufacturing Practice for medicinal products, self-inspections should be performed in order to supervise the GMP process within a company and to propose necessary improvements. GMP self-inspections are also useful to prepare for inspections by official authorities and/or by customers and to permanently challenge and improve the GMP status of the company. Self-inspections can be performed as periodic systemic inspections or as product- or procedure related inspections (routine self-inspections) or as „for-cause audits“ e.g. after complaints or when quality control results are not in accordance with their specifications, and to prepare specifically for an audit by official authorities or by customers (the latter ones are non-routine self-inspections). Key words Auditoren-Qualifikation • Audit-Vorbereitung • Behörden-Audits • GMP • Selbstinspektionen |
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pharmind 2004, Nr. 10, Seite 1255