ABSTRACT
The European legislation does not require mandatory routine GMP inspections for active substance manufacturers. Responsibility for using only active substances that have been manufactured in accordance with good manufacturing practice is placed on the holders of a manufacturing authorization. Art. 111 Directive 2001/83/EC (Art. 80 Directive 2001/82/EC for veterinary medicinal products), however makes provision for GMP inspections of active substance manufacturing sites to be carried out at the request of the manufacturer itself. The request for the inspection should be made to the EEA competent authority where the site is located or, in case of sites located in third countries, to a competent authority where the active substance is used as a starting material in the manufacture of medicinal products. If this is not the case, any EEA authority can be approached. There is no guarantee that such a request will be fulfilled, as the competent authorities need to balance such requests with other priorities. It should also be borne in mind that an inspection does not replace the responsibility of the manufacturing authorization holder using the active substance in question as a starting material and will not be accepted alone as adequate assurance that the manufacturing authorization holder has fulfilled its responsibilities.
