Naslov
Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities

Autori
Tomić, Siniša ; Sučić, Anita ; Martinac, Adrijana

Izvornik
Archives of Industrial Hygiene and Toxicology (0004-1254) 61 (2010), 4; 425-436

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, ostalo

Ključne riječi
inspection ; medicinal product ; production ; quality assurance ; quality control ; qualified person

Sažetak
In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certifi cate, and the Certifi cate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insuffi cient resources may have a direct bearing on patients by limiting their access to affordable treatment.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

POVEZANOST RADA