GMP/GDP Certificate

Manufacturing and import license and GMP certificate 

- Your pharmaceutical/biotech start in the EU - 

If you like to manufacture medicinal products and/or investigational medicinal products in the European Union or wish to import them into the EU (in future also from Great Britain!), you need the respective manufacturing/import license and the corresponding GMP certificate.

After submission of the respective license application, the supervisory authority will carry out an on-site inspection to verify compliance with EU Good Manufacturing Practices . In Germany the respective authority has to decide upon the application of the license within three months (§ 17 Abs. 1 AMG).

For the license, you must have established an appropriate quality management system, which demonstrates suitable measures to ensure the proper quality and safety of the medicinal products according to EU standards. In particular, Standard Operating Procedures must describe internal processes, the suitability of all premises and equipment must be demonstrated and the conformity of materials, the qualification of personnel as well as the quality of external services must be ensured and properly documented.

Our team of experts offers a comprehensive service:

  • Application
  • Creation of the Site Master File
  • Preparation of Standard Operating Procedures (SOPs) and related forms
  • Qualification of premises, installations and equipment as well as associated documentation
  • Validation of processes, systems and methods
  • Support for the selection of key staff members
  • Identification and selection of external service providers and suppliers
  • Audits and contractual agreements for external services (e.g. supplier, analysis, transport)
  • Audits in order to issue the QP-declaration, necessary for the import of medicinal products into the EU
  • Training of employees
  • Mock inspection: to prepare for the inspection
  • Support during the inspection

Of course, we also support the extension of your license/ GMP certificate or in preparing for the regular triennial inspection.

With our expertise you will achieve the pharmaceutical/biotech market access in the EU within short time!

  • GDP & Wholesale Licence

    Wholesale distribution authorization and GDP certificate

    - Your pharmaceutical distribution in the EU -

    As a pharmaceutical wholesaler in Germany and Europe, you are responsible for ensuring that the quality and integrity of medicinal products are maintained throughout all activities carried out, such as procurement, storage, dispensing and export, and that no counterfeit medicines enter the legal supply chain.

    To guarantee this, a wholesaler in Germany needs a wholesale distribution authorization according to § 52a AMG. The application for the wholesale distribution authorization must be submitted to the appropriate state authority. The authority checks whether you comply with the Verordnung über den Großhandel und die Arzneimittelvermittlung (Arzneimittelhandelsverordnung - AM-HandelsV) and the EU Guidelines on Good Distribution Practice (GDP) for medicinal products (2013/C 343/01).

    These regulations specify the implementation of a quality management system, which sets out the responsibilities, procedures and principles of risk management in relation to your sales activities. Furthermore, you must provide at least one responsible person who is responsible for the proper operation and compliance with the regulations. Your premises, facilities and equipment must ensure the proper storage and distribution of the medicinal products. As a wholesaler, you must ensure that you purchase the drugs you distribute only from the manufacturer (holder of a manufacturing authorization according to § 13 AMG) or other holders of a wholesale distribution authorization. You are obliged to check with other wholesalers to ensure that they comply with the guidelines of Good Distribution Practice and must check that they hold a wholesale distribution authorization.

    Our team of experts offers a comprehensive service:

    • Application (according to § 52a AMG)
    • Development of a quality management system and preparation of the QM manual
    • Creation of Standard Operating Procedures (SOPs) and related forms
    • Qualification of premises, facilities and equipment as well as associated documentation
    • Validation of processes and systems
    • Performance of temperature distribution studies
    • Support in the selection of personnel in key positions (e.g. responsible person)
    • Identification and selection of external service providers
    • Audits and contractual agreements for external services (e.g. transport, storage)
    • Training of your employees
    • Mock inspection in preparation for the inspection
    • Support during the inspection

     

    With our experienced staff you will receive your wholesale distribution authorization as well as the GDP certificate within a very short time!

We are there for you

Contact us if you have any questions. We will gladly answer and advise you.

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