Pandemija COVID-19 mijenja uobičajen pristup u nadzoru nad dobrom proizvođačkom praksom ; COVID-19 Pandemic Alters Conventional Approach of Good Manufacturing Practice Inspection

In: Kemija u industriji : Časopis kemičara i kemijskih inženjera Hrvatske ; ISSN 0022-9830 (Print) ; ISSN 1334-9090 (Online) ; Volume 70 ; Issue 7-8, 2021

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Dobra proizvođačka praksa (GMP) je skup različitih smjernica, pravila i normi koje jamče učinkovitost, kvalitetu, sigurnost i dosljednost u proizvodnji i kontroli lijekova. Nadzor nad dobrom proizvođačkom praksom u Hrvatskoj provodi Agencija za lijekove i medicinske proizvode (HALMED). U svrhu održavanja konzistentnih inspekcijskih standarda, HALMED ima razvijen Poslovnik kakvoće izrađen u skladu s europskim smjernicama. Inspektori Agencije imaju odgovarajuća znanja i iskustvo te se trajno usavršavaju. Po obavljenoj inspekciji, HALMED izdaje proizvodnu dozvolu i potvrdu o provođenje dobre proizvođačke prakse (GMP potvrdu) za proizvođače u Republici Hrvatskoj te GMP potvrdu za proizvođače iz trećih zemalja. S obzirom na nemogućnost izlaska inspektora na teren uslijed pandemijske situacije, sve se češće pribjegava ocjeni na daljinu. ; 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.

Titel:	Pandemija COVID-19 mijenja uobičajen pristup u nadzoru nad dobrom proizvođačkom praksom ; COVID-19 Pandemic Alters Conventional Approach of Good Manufacturing Practice Inspection
Link:	https://hrcak.srce.hr/259347 https://doi.org/10.15255/KUI.2020.061 https://hrcak.srce.hr/file/377172
Zeitschrift:	Kemija u industriji : Časopis kemičara i kemijskih inženjera Hrvatske ; ISSN 0022-9830 (Print) ; ISSN 1334-9090 (Online) ; Volume 70 ; Issue 7-8, 2021
Veröffentlichung:	2021
Medientyp:	academicJournal
DOI:	10.15255/KUI.2020.061
Schlagwort:	Agencija za lijekove i medicinske proizvode nadzor dobra proizvođačka praksa proizvodna dozvola nedostatci Agency for Medicinal Products and Medical Devices inspection good manufacturing practice manufacturing license deficiencies
Sonstiges:	Nachgewiesen in: BASE Sprachen: Croatian Collection: Hrčak - Portal of scientific journals of Croatia / Portal znanstvenih časopisa Republike Hrvatske Document Type: article in journal/newspaper File Description: application/pdf Language: Croatian Rights: info:eu-repo/semantics/openAccess ; Journal "Kemija u industriji" is an Open Access journal at the highest possible level meaning that all content is immediately and freely available to anyone, anywhere, to be downloaded, printed, distributed, read, reused, self archived, and remixed (including commercially) without restriction, as long as the author and the original source are properly attributed according to the Creative Commons Attribution 4.0 International License (CC BY). The author(s) hold the copyright and retain publishing rights without restrictions. CC BY (Creative Commons Attribution) is the most accommodating of public copyright licenses as defined by Creative Commons, a nonprofit organization that provides legal tools for sharing and use of creative works and research. The CC BY license is recommended for maximum dissemination and use of licensed materials. All content published in Kemija u industriji is available under CC BY, meaning anyone is free to use and reuse the content provided the original source and authors are credited. The copyright is held and retained. The author(s) hold the copyright without restrictions CC BY is the appropriate license for publicly funded research; it maximizes the potential for both economic and scholarly impact, protects the rights of authors and strengthens the long-standing tradition of appropriate attribution and credit for scholarship. Journal does not charge neither article processing charges (APCs) nor article submission charges. Self-archiving policy Sherpa/ROMEO blue route since 2013. All published manuscripts are licensed under a Creative Commons Attribution 4.0 International License.

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