GMP/GDP Certificate
Manufacturing license according to § 13 AMG & 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, you need the respective permission 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 Practice. The respective authority has to decide upon the application for the permission of the GMP license for the manufacturer or import/export of medicinal products within three months (§ 17 Abs. 1 AMG).
Without a QMS no manufacturing license
For the GMP certification, you must have established an appropriate quality management system, QMS, which demonstrates suitable measures to ensure the proper quality and safety of the medicinal products according to EU standards. In particular, Standard Operating Procedures, SOPs, 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.
If you need support on the way to the GDP certificate our team of GMP experts offers comprehensive consulting services for:
- Application
- Creation of the Site Master File
- Preparation of SOPs and related forms
- Qualification of 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 (e.g. supplier, analysis, transport)
- Audits (supplier qualification) and preparation of contractual agreements for external services
- GMP/GDP training of employees
- Preparation on and 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 fulfill the GMP requirements and achieve the pharmaceutical/biotech market access in the EU within short time!
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GDP & Wholesale Licence
Wholesale distribution authorization acc. 52a AMG and import/export permission acc. to § 72 -74 AMG & 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 if no manufacturing authorization according to § 13 AMG has been established already. As far as EU import from countries outside European Economic Area according to § 72-74 AMG will be included, an appropriate permit must be obtained. 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).
Without a QMS no GDP certificate
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 in charge of 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 the drugs you distribute are produced by manufacturers with a (manufacturing authorization according to § 13 AMG) or from holders with a wholesale distribution authorization. You are obliged to check that wholesalers you work with comply with the guidelines of Good Distribution Practice and that they hold a wholesale distribution authorization.
After successfully completing the GDP audit by the supervising state authority (in Germany), you will receive your wholesale distribution authorization so called GDP certificate. To ensure long-term compliance with the requirements, surveillance audits are carried out (every 12 to 24 months), a recertification is due after 3 years.
To ensure that you receive the GDP certificate promptly, our team of experts offers the following services:
- Application (according to § 52a AMG)
- Preparation of the QP-declaration, necessary for the import of medicinal products into the EU
- Implementation of a QMS and preparation of the QM manual
- Creation of Standard Operating Procedures (SOPs) and related forms
- Qualification of facilities and equipment as well as associated documentation
- GMP/GDP-compliant warehouse qualification
- Validation of processes, systems and methods
- GDP-relevant computerized system validation (inventory control and warehousing system)
- Performance of temperature mappings
- Support in the selection of personnel in key positions (e.g., responsible person)
- Identification and selection of external service providers (e.g., transport, storage)
- Audits and contractual agreements for external services
- GMP Training of your employees
- Mock inspection in preparation for the inspection
- Support during the inspection
Contact us now and benefit from our experience of more than 20 years of GMP consulting. Our experts will explain to you how to obtain a GMP or GDP certificate. After the free initial consultation, we will promptly prepare an offer for accompanying consulting or even practical support.
