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API trading

QP: Who is the Qualified Person and why does CSV ACTIVE need him?

Tommy Barzetti has become our QP and you can meet him in this short video…

The QP is a crucial figure for CSV Active, as Tommy explained. To understand why, let’s step back a little… CSV Active, founded in 2013, was established to complete the wide spectrum of the services offered by CSV Life Science Group, being a worldwide qualified partner with high expertise in Fine Chemical Intermediates and API (Active Pharmaceutical Ingredients) research for the chemical and pharmaceutical market.

CSV Active can rely on qualified people working in the core business of intermediates and API trading are linked to a highly efficient and qualified network of suppliers to fulfil the technical and regulatory requirements operating mainly in Europe.

AIFA-authorised warehouse.

CSV Active has recently reached an agreement with an AIFA-authorised external warehouse for the storage of APIs and has therefore become able to offer its customers this service too.
CSV Active’s ongoing quest to satisfy its customers means that it is always working to increase its product catalogue. To date, a further three authorised active ingredients OMEGA 3, THIOPRONIN and AZITHROMYCIN have been added, with more on their way.
Operating in a highly controlled market, CSV Active is always ready to adapt to European regulations in order to stay on track and provide a high and efficient service.
In recent years, new laws In recent years, new laws issued by the European Union and immediately implemented by Italian legislation have turned the tables. Indeed, with the new regulations the importation of medicines or active ingredients has become a production activity, whereby importation is now considered part of production. It has therefore become necessary to become a pharmaceutical workshop with a QP. Of extreme importance, the QP is the person who represents the company to the national control body in terms of the quality of the pharmaceutical product produced. Immediately, CSV Active activated the application to become an Import Pharmaceutical Workshop and to find a QP to be confirmed.
In January 2019, CSV Active was granted by AIFA (the Competent Authority in Italy) the GMP Certificate for the import and distribution of Active Substances to manufacturers of medicines/active substances for human use.

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