GMP Inspections

Arrangement of GMP inspections

The National Institute of Pharmacy – as the responsible authority for the supervision of manufacturing medicinal products – makes certain through their colleagues working as GMP inspectors that manufacturing of medicinal products meets the requirements stated in the Marketing Authorisation and is proceeded according to GMP directives.

Purpose of GMP inspections

If an economic organization applies for a manufacturing authorisation for medicinal products or active substances the condition of issuing the licence is a successful local GMP inspection.

Following the above mentioned process the manufacturing site owning manufacturing authorisation for medicinal products is being inspected regularly by the competent authority to follow the activity of manufacturing of medicinal products with attention continuously. According to the EU requirements frequency of these GMP inspections is in case of a medicinal product once in two or three years’ time and occasional in case of an active substance.

The National Institute of Pharmacy has the right to make an exceptional GMP inspection if a fault with the quality or with the manufacture of the medicinal product or if any changes in the circumstances concerning the manufacturing process or quality of the medicinal product (e.g essential change in the places or equipment) occurs.

During the process of granting a Marketing Authorisation for a medicinal product it may become necessary to make a GMP inspection at a manufacturing site in a so called „third country” beyond inspecting the Hungarian manufacturers – the inspectors of the National Institute of Pharmacy will carry these inspections as well out.

For example:

• during the process of marketing authorisation if the medicinal product or the active substance is manufactured in a third country;
• if requested by a foreign professional organization (e.g. EMEA, EDQM) or a national authority;
• if requested by the manufacturer (whether of the raw material, or the active substance; or the transporter of intermediate or final product; or as a customer).