For pharmaceutical companies and their suppliers, there is a full set of legal requirements to be installed and maintained within the framework of a quality system. There are extensive obligations for the pharmaceutical manufacturers regarding supplier control, which may be supported by respective certification systems.
Many suppliers to the pharmaceutical industry use the worldwide recognized standard EN ISO 9001 as a basis for their quality system, which may be amended accordingly if there are special requirements regarding their products or services.
Suppliers of primary packaging materials can use EN ISO 15378 as a quality standard, which contains GMP requirements specifically for this sector in addition to ISO 9001 requirements. We are one of the few registrars in Europe which are accredited for this standard.
Some medical devices are, with respect to their characteristics and manufacturing technology, similar to pharmaceutical products. Therefore a significant number of pharmaceutical companies also function as medical device manufacturers or subcontractors for production of medical devices. In such cases the full range of certification services applicable for medical devices, such as Directive 93/42/EEC, EN ISO 13485 or EN ISO 9001 may be used by pharmaceutical companies.
Amongst our auditors and experts we have a range of skilled persons experienced in the pharmaceutical sector and, therefore, particularly qualified to perform audits in this specific area.