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Pharmaceutical Inspectorate
Introduction
We, Michael Martens and Juergen Rassmann, are civil servants of the City of Hamburg in Germany. We are pharmacists and GMP-inspectors. This GMP-inspection is performed on the request of a company located in Hamburg.
The Hamburg Company needs a GMP- certificate either - to import the API / drug product or - in order to apply for a marketing authorization. The pharmaceutical inspectorate of the BGV Hamburg performs this inspection, because the applicant (i.e. the company) is located in the City of Hamburg.
The Federal Republic of Germany is made up of 16 largely independent states (Lnder), one of which is Hamburg. In many respects the German states (Lnder) organize the control of pharmaceutical products on their own.
Germany has a federal system for the inspection but a central system (BfArM) for the marketing authorization of medicinal products.
Germany has implemented all the relevant EU-directives and guidelines into German law.
There are some requirements in the German drug law which are different from those in other European countries.
Example: the import of APIs from human, animal or microbial origin into Germany always triggers an inspection. Other EU countries have different regulations.
German authorities inspect solely on request of - German companies or - European or German regulatory authorities.
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What is the Link between BGV, Hamburg Company and non-European Manufacturer?
The BGV makes sure, that the Hamburg applicant adheres to the relevant German and European Regulations. The BGV either grants or refuses the import. As a consequence the importing German company is expected to ensure that all relevant requirements are met by non-European manufacturers.
The BGV cannot make a company outside its jurisdiction adhere to the requirements of the Guidelines of the European Union but we can and will refuse the import of products, which are not manufactured according to EUGMP.
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Confidentiality
The BGV Hamburg - Inspectors are civil servants of the City of Hamburg. German law obliges us to treat any information obtained during the course of the inspection with the utmost confidentiality. As we proceed with the inspection, we may request to see areas which are not directly related to the manufacture of the product. We nevertheless expect you to comply, because the overall policy of the company is subject to our inspection. In other words: we need the whole picture, not a part of it. If necessary, the representative of the German company can be excluded from that particular part of the inspection.
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Yes, the inspection and the GMP-certificate are valid in all of the 27 member states of the European Union.
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Serious GMP-non-compliance
The EMA is establishing a system of information about companies which were found to be non-compliant with the GMP rules. This Information will be distributed to all European Member states and the EDQM
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Schedule:
Day 1: Opening meeting Walk around the facility Warehouses Documentation and Quality assurance Day 2: Production Documentation and Quality assurance Day 3: Quality control Documentation and Quality assurance Final meeting
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Thank You
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