Witold Wieniawski, Zofia Ulz

Osoba wykwalifikowana - wymagania prawne i rozwiązania praktyczne

Qualified person legal requirements and practical approaches. Legislation at present in force in Poland related to qualified person responsible for batch release is reviewed and compared with relevant European Union directives. Position of the qualified person in the overall quality system established according to GMP requirements is discussed. Duties of a qualified person responsible for the release of imported medicinal products are also examined. The situation of other responsible persons nominated according to regulations governing pharmaceutical production and distribution is also mentioned.