Our company is inspected regularly by the competent supervisory authorities and has the following authorisations:
- GMP Certificate
- GDP Certificate
- Manufacturing authorisation in accordance with § 13.1 German Drug Law [AMG]
- Wholesale authorisation in accordance with § 52a German Drug Law [AMG]
- Legal permit to handle narcotics in accordance with § 3 German Narcotics Act [BTMG] for domestic and foreign trade
- Certificate for Quality Management System in accordance with DIN EN ISO 9001 (2015)
In addition, the general legal and official regulations as well as the provisions of the trade association are complied with in their currently applicable versions.
Our activities lie, without exception, within the framework of the statutory provisions. Predominant use is made, in particular, of the
- German Drug Law [AMG]
- the German Ordinance on the Production of Pharmaceuticals and Active Substances [AMWHV]
- the Ordinance on Trade with Medicinal Products [AM-HandelsV]
- the EU guidelines to GMP
- the EU guidelines to GDP
- the German Narcotics Act [BTMG]
and these are correspondingly incorporated into our standard operating procedures. Our control processes are optimised within the framework of self-inspections which are conducted several times a year and also in accordance with customer requirements so that we can always ensure the smooth functionality of all processes.