Norme GMP - Stato GMP

09:38 Jan 16, 2024
Italian to English translations [PRO]
Manufacturing
Italian term or phrase: Norme GMP - Stato GMP
"Il lotto è stato confezionato in accordo alle norme GMP, applicando il metodo approvato e eventuali deviazioni sono state notificate secondo xxx."

"Lo stato dei locali secondo xxx "Identificazione dello stato GMP di locali e macchine e controllo degli accessi in funzione dello stato dei locali"

Si tratta di un documento di produzione farmaceutica.
Virginia Conti
Italy
Local time: 09:17


Summary of answers provided
4 +1GMP rules - GMP compliance / compliance with GMP
martini


  

Answers


3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
GMP rules - GMP compliance / compliance with GMP


Explanation:
Le GMP - Good Manufacturing Practices - in italiano anche dette norme di buona fabbricazione - NBF - sono un insieme di regole e procedure a cui ogni azienda deve attenersi per assicurare che i propri prodotti rispettino i più alti standard di qualità.
...
Sviluppate inizialmente per i farmaci, l'applicazione delle GMP si è poi estesa al settore alimentare, dispositivi medici, derivati biologici, cosmetici e alimenti per animali.
https://www.connectendress.it/gmp-norme-buona-fabbricazione

GMP (Good Manufacturing Practice) is the part of quality assurance that ensures consistent quality standards in the production and testing of medicinal products or active ingredients (APIs).

GMP rules are the requirements for quality assurance of the manufacturing processes and environment formulated by the European Commission in the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use and active pharmaceutical ingredients.
https://www.gmp-compliance.org/what-is-gmp#gmpreg

Who monitors GMP compliance?

"Confirmation of a manufacturer's compliance with GMP".
https://www.gmp-compliance.org/what-is-gmp#gmpmon

martini
Italy
Local time: 09:17
Native speaker of: Italian
PRO pts in category: 18

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