Professional paper

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 ; Agency for Medicinal Products and Medical Devices (HALMED), Ksaverska cesta 4, 10 000 Zagreb, Croatia
Martina Bencetić Marijanović ; Agency for Medicinal Products and Medical Devices (HALMED), Ksaverska cesta 4, 10 000 Zagreb, Croatia
Siniša Tomić orcid.org/0000-0002-3500-9940 ; Agency for Medicinal Products and Medical Devices (HALMED), Ksaverska cesta 4, 10 000 Zagreb, Croatia

Abstract

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.

Keywords

Agency for Medicinal Products and Medical Devices; inspection; good manufacturing practice; manufacturing license; deficiencies

Hrčak ID:

259347

URI

https://hrcak.srce.hr/259347

Publication date:

24.6.2021.

Article data in other languages: croatian

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