Brenntag has been GMP-certified for years. The GMP guidelines are prescribed in law in the Pharmaceuticals Act (AMG) and the Pharmaceuticals Regulation (AMBO) as well as EU Directive 2003/94/EC. These guidelines regulate quality management in the production and marketing of pharmaceutical active ingredients.
The activities of Brenntag Austria GmbH in the pharmaceutical sector are limited to the refilling of pharmaceutical ingredients (API) and fillers from large containers to small containers for magistral use. This area is thus subject to the General Pharmaceutical Regulations (AMBO).
A quality management system that meets the requirements of “good manufacturing practice” for pharmaceuticals is required for these products. Compliance with the provisions of these regulations is regularly checked and audited by the Austrian Federal Office for Safety in Health Care (BASG) and the Austrian Agency for Health and Food Safety (AGES), which are responsible for the supervision and registration of pharmaceuticals and medical products. The certificate on compliance with the specifications of “good manufacturing practice” is one of the main statutory bases for the refilling of active and auxiliary ingredients carried out by Brenntag in the pharmaceutical sector.