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GMP-Audit zur Qualifizierung von Lohnauftragnehmern und Lieferanten

Xaver Fischer a , Dorothee Heer b und Beat Sägesser c

Pharma Consulting a , Riehen, Schönenberger Pharma AG b , Brugg, und Siegfried CMS AG c , Zofingen (Schweiz)

GMP Audit for the Qualification of Contract Manufacturers and Suppliers

Qualification and audits of contract manufacturers and suppliers are becoming increasingly important for the pharmaceutical industry. On the one hand, the authorities issue more detailed and comprehensive requirements which do not affect finished products alone and on the other hand, it is in the interest of pharmaceutical companies to guarantee the client a high quality of their products according to harmonised demands on this quality.
Through controlled, harmonised quality and the results of audits, the effort required for analytical and technical entry controls, be it for finished products, active ingredients or, for example, packaging materials, can be minimised. At the same time, audits and qualification require personnel and financial resources for the purchaser and the supplier. The following report is an attempt to develop a useful and economical plan for audits and qualifications, based on Swiss and European guidelines. This will help in the choice of companies to be audited and the evaluation of the audits.
In addition to the benefits of audits, the limits and risks are discussed too: the quality assessment of a contractor or supplier relies on the economic dependence of the contractor on the supplier and on the authorities’ requirements when a change of supplier occurs.

Key words Audit · GMP · Lieferanten · Lohnauftragnehmer · Qualifizierung