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Ministry of Health and Consumer Protection

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.

What is the function of the BGV?


The BGV is the regulatory authority for all companies located in Hamburg trading in pharmaceutical products (APIs, finished dosage forms etc.). The BGV issues import licences for companies located in Hamburg, listing specified products GMP certificates for specified products. Both documents are issued to the applicant in Hamburg. They list the manufacturer of the pharmaceutical product, the workshop it was manufactured in and the name of the product. The BGV will recall certificates or refuse the import of the product if any illegal or non-GMP-activities become known. We do not issue GMP-certificates for non-European companies.

How is Germany organized with respect to the control of pharmaceutical products?

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.

Regulatory Differences within the EU (1)


The Federal Republic of Germany is one of the 27 Member States of the European Union (EU). Is there a common European law?

Yes and No:


EU-Directives and Guidelines issued by the EU must be implemented into the different legal systems of the member states. EU-Regulations are enforced without the need for any implementation by the member states. Because of the differences in the legal systems of the member states there may be differences as to the requirements concerning the import of pharmaceutical products.

Regulatory Differences within the EU (2)

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.

Which companies need to be inspected?

All suppliers outside the European Union manufacturing

- APIs from human, animal or microbial origin and APIs


containing genetically modified material

- APIs from chemical origin on request of European or


German authorities granting marketing authorizations (EMA, BfArM)

- medicinal products (finished dosage forms)

Who can apply for an inspection?

German authorities inspect solely on request of - German companies or - European or German regulatory authorities.

Definition of Significant Deficiencies


Critical Deficiencies (F1) deficiencies which have produced or lead to a significant risk of producing a product which is harmful to the patient. Major Deficiencies (F2) non-critical deficiencies, which have produced or may produce a product, which does not comply with its marketing authorisation, which indicate a major deviation from EU-GMP, a combination of several other deficiencies, none of which on their own may be major, but which together represent a major deficiency. Other Deficiencies (F3) deficiencies, which cannot be classified as either critical or major, but which indicate a departure from EU-GMP.

Categorization of deficiencies with respect to the outcome of the inspection


In case we observe any deficiencies, the outcome of the inspection depends on the nature of the deficiencies: Critical deficiencies necessitate a re-inspection. No GMP-certificate can be granted. Major deficiencies means, a GMP-certificate is granted only if the deficiencies are addressed and the corrective action plan has been reviewed by the inspectors with a satisfactory outcome. Other deficiencies have to be addressed and removed. GMP-certificate is granted.
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What happens after the inspection ? (1)


An inspection report will be issued in the German language and sent to the company which applied for the inspection.
The company will translate the report and pass it on to the inspected company. The inspected company is expected to reply by way of the German company - within 3 months, giving a corrective action plan.

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What happens after the inspection? (2)


The inspectors will review the corrective action plan. If the plan is satisfactory, a GMP-certificate will be issued, listing the name of the applicant, the name and address of the inspected company, all sites and workshops used in the manufacturing and the name of the inspected product. The certificate is valid for a maximum of three years. Any major alterations to the manufacture, such as using new rooms, different starting materials, major changes to the process, etc., must be reported to the Hamburg company, who will report back to the pharmaceutical inspectorate of the BSG. We will then decide whether a further inspection is necessary.
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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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Is the inspection valid throughout Europe?

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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Ministry of Health and Consumer Protection

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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Ministry of Health and Consumer Protection

Thank You

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