Abstract

GMP inspections from an inspector’s point of view

In Germany, inspections are carried out by competent authorities of the federal states based on Section 64 of the German Drug Law. The inspections generally fulfill all relevant EU requirements. Commission Directive 2003/94/EC calls the EU member states to take into account the compilation of Community procedures on inspections and exchange of information. The quality assurance system mentioned in the compilation has been implemented in Germany before 2000. Since its implementation, it has been rated as equivalent by different EU Mutual Recognition Agreement (MRA) partners. The different components of the quality system were drafted under co-ordination of the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) by different inspectors’ expert working groups. Standard operating procedures focusing on the inspection system as well as Aide mémoires (both are components of the quality system) are presented.

GMP inspectors in training have to complete a 2-year training program including theoretical education; they also have to carry out a fixed number of inspections before they become an inspector. Inspectors’ performance is examined and judged regularly. GMP inspectorates have to set up a yearly inspection program; adherence to this program is to be checked on a regular basis. Inspection planning takes into account the manufacturers' compliance levels and the risks of the products manufactured. Preparation and performance of GMP inspections are laid down in binding documents. Inspection findings are evaluated in accordance with standard operating procedures. Furthermore, situations where GMP inspections must be performed in countries outside of the EU and the EEA, and how GMP supervision in Germany might look like in the near future, are highlighted.

Rico Schulze hat Pharmazie und Betriebswirtschaftslehre studiert. Zwischen 2001 und 2019 war er als GMP- und GDP-Inspektor in der Arzneimittelüberwachung des Freistaats Sachsen beschäftigt. Von 2009 bis 2011 und seit 2019 arbeitet er als Referent für Arzneimittel- und Apothekenrecht im Sächsischen Staatsministerium für Soziales und Gesellschaftlichen Zusammenhalt.