Other GMP certificates

Because of all the reasons named above, there exists no GMP certificate for companies that e.g. develop apparatus for the pharmaceutical construction or other services relating to manufacturing like engineering, IT systems etc. The pharmaceutical manufacturer is responsible for the selection of the service providers and suppliers. Within the structure of a supplier qualification, the pharmaceutical manufacturer (respectively the head of production and the head of quality control) have to demonstrate that the company did examine the selected suppliers initially and then on a standard basis. The qualification of suppliers must rely on a risk-based approach.

For suppliers whose products have a low potential risk to unwearied safety, self-evaluation forms may be sufficient. On the contrary, products which pose a potential high risk to unwearied safety (e.g. all APIs) have to be audited by the pharmaceutical manufacturer.