Privatsphäre-Einstellungen

Durchführung und psychologische Aspekte eines Follow-up von Inspektionen

Unter besonderer Berücksichtigung der neuen Schweizer Inspektionsrichtlinien vom 19. 11. 1998

Andreas G. Faeh a , Richard M. Söll b und Dieter Bachmann c

Ciba Vision a , Hettlingen, Eidgenössisch-Technische Hochschule Zürich, Departement Pharmazie b , Zürich, und RWJ Pharmaceutical Research Institut c , Schaffhausen (Schweiz)

Conduct and Psychological Aspect of Inspection Follow-ups / With special regard to the new Swiss inspection guidelines as of 19 /11 /1998

Conduct of inspections of pharmaceutical manufacturers in Switzerland is guided by the new inspection guidelines of the „Interkantonale Kontrollstelle für Heilmittel“ (IKS) which came into force at the beginning of 1999. Biannual inspections shall ensure the maintenance and improvement of standards of high production quality. The intention of the inspection guidelines is a harmonisation in inspection practice and in the interpretation of the rules of Good Manufacturing Practice (GMP) throughout all Swiss cantons. The special situation in Switzerland by having federal, regional and cantonal authorities may lead to certain differences in the interpretation of GMP standards. The „Gesundheitsgesetz“ and the approval of manufacturing permission is under the control of the canton. A nationwide harmonisation could be easily achieved if the cantons would abdicate responsibility. This would mean introducing a common federal law, which would certainly facilitate future harmonization. The recommended rating of observations only makes sense if applied to everyone using the same interpretation of the guidelines.
Probable enormous amounts of money needed to fulfil corrective actions after inspections should be budgeted in advance. This will help to overcome a certain psychological pressure situation. A good human resource management is required to cope with stress during and after inspections and to gain a positive response by the staff. The synergistic teamwork of people coming from different groups such as employees, management and inspectors gives a great potential for improvement. Recognition, understanding of everyone’s needs and motivation are the keys to success. Respecting these psychological aspects within inspections will give success to the inspection procedure and make it a highlight of quality assurance management.

Key words Good Manufacturing Practice · Inspektionen, Follow-up, psychologische Aspekte, Rating · Interkantonale Kontrollstelle für Heilmittel