Sourcing of starting materials and active pharmaceutical ingredients from third countries is common practice, particularly in the production of generics. The main supplier countries are China and India.
Certificates of suitability (CEP), ISO or GMP certificates from these third countries are not sufficient proof of the compliance with GMP Guidelines for the production of a pharmaceutical product. Only an API audit for a specific active pharmaceutical ingredient which is performed on site is accepted by the regulatory authorities as proof of the GMP compliance of the API manufacturer. Such an GMP audit must be performed regularly, every two to three years. A GMP audit in the form of a third party audit by contract partners is explicitly permitted.