Stručni rad
https://doi.org/10.15255/KUI.2020.061
COVID-19 Pandemic Alters Conventional Approach of Good Manufacturing Practice Inspection
Teo Kolonić
orcid.org/0000-0002-4548-2555
; Agencija za lijekove i medicinske proizvode (HALMED), Ksaverska cesta 4, 10 000 Zagreb
Martina Bencetić Marijanović
; Agencija za lijekove i medicinske proizvode (HALMED), Ksaverska cesta 4, 10 000 Zagreb
Siniša Tomić
orcid.org/0000-0002-3500-9940
; Agencija za lijekove i medicinske proizvode (HALMED), Ksaverska cesta 4, 10 000 Zagreb
Sažetak
Good Manufacturing Practice (GMP) is a set of different guidelines, rules and standards that guarantee effectiveness, quality, safety and consistency in manufacturing and quality control of medicinal products. To maintain consistency in inspection standards, HALMED has in place a Quality Manual developed according to European guidelines. The Agency inspectors are trained and experienced accordingly, and are permanently educated. After an inspection has been completed, HALMED issues a manufacturing license and a GMP certificate for manufacturers located in the Republic of Croatia or a GMP certificate for manufacturers from third countries. Due to the pandemic situation that prevents inspectors to travel to manufacturing sites abroad, they proceed with the distant assessment of manufacturers.
Ključne riječi
Agency for Medicinal Products and Medical Devices; inspection; good manufacturing practice; manufacturing license; deficiencies
Hrčak ID:
259347
URI
Datum izdavanja:
24.6.2021.
Posjeta: 858 *