To ensure that the requirements of the operational regulations stipulated by law for pharmaceutical manufacturers, including the GMP directive 91/356/EEC are being met, regular inspections need to be carried out.

With our experts, who have many years’ experience in the pharmaceutical industry, we carry out inspections - in your own company and also at your suppliers.

• The aims of an inspection are
  
  • to identify weaknesses with regard to the activities and requirements described in the quality assurance system;
  • to check whether the measures determined on the basis of earlier inspections have been carried out and have proved successful.
• Inspections are recommended in particular for those departments which involve medical and scientific work, development, manufacture, testing, storage and logistical management of products. These include the Medical Department, Pharmacovigilance, Regulatory Affairs, Marketing, Quality Assurance, Production, Quality Control and Distribution.
• Depending on the structure of a company, inspections may cover one or more departments or also individual issues and should be carried out frequently to ensure that all areas or departments are inspected at least once in a cycle of 2 years. If certain areas are found to be critical, we recommend conducting inspections at shorter intervals.

After completion of every inspection, we submit a report which specifically and precisely describes the status and proposes measures.