Privatsphäre-Einstellungen

Erfahrungen beim Erstellen und Anwenden von Checklisten für Selbstinspektionen

Bruno Keller a , Susanne Moritz b , Andre´ Nick c und Brigitte Schulthess d

Vifor (International) AG a , St. Gallen, Solco AG b , Birsfelden, The R. W. Johnson Pharmaceutical Research Institute, A Division of Cilag AG c , Schaffhausen, und Phytomed AG d , Hasle bei Burgdorf (Schweiz)

Experiences Collected during Compilation and Application of Checklists for Self Inspections

The present paper is dealing with experiences collected during compilation and application of checklists for self inspections. The main emphasis lies on a checklist for self inspections of quality control laboratories, based on several regulations and specific literature. In order to gain practical experience in applying checklists, the two topics “instrumentation” and “computerized systems” were inspected in a pharmaceutical company. The paper is demonstrating advantages as well as disadvantages of applying checklists. Checklists can serve as a useful tool for a thematically well structured inspection. Already the structuring and wording of the checklist can decide whether a self inspection will end up successfully or not. However, checklists do not replace a careful preparation of a self inspection. Furthermore, experience and professional knowledge are additional criteria to form a successful self inspection. Taking these results into consideration, checklists can serve as a valuable tool for analyzing the current GMP status of a pharmaceutical company.

Key words Checklisten · Qualitätskontrolle · Selbstinspektion