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Il produttore di alta tecnologia by Abdoul Hamid Derra

Il produttore di alta tecnologia

by Abdoul Hamid Derra
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Book cover type: Paperback
  • ISBN13: 9786207823345
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Edizioni Sapienza
  • Publisher Imprint: Edizioni Sapienza
  • Publication Date:
  • Pages: 220
  • Original Price: GBP 69.51
  • Language: Italian
  • Edition: N/A
  • Item Weight: 300 grams
  • BISAC Subject(s): General

Queste buone pratiche provengono dalla parte II della guida europea alle buone pratiche di fabbricazione dei medicinali per uso umano e veterinario, a sua volta tratta dalla guida ICH Q7A sviluppata dalla conferenza internazionale di armonizzazione (ICH). Queste buone pratiche hanno lo scopo di fornire una guida alle buone pratiche di fabbricazione (GMP) per la fabbricazione di sostanze attive nell'ambito di un adeguato sistema di gestione della qualit�. Hanno inoltre lo scopo di fornire assistenza nel garantire che le sostanze attive siano conformi ai requisiti di qualit� e purezza che dichiarano o che si prevede abbiano. In queste buone pratiche, la "Produzione" comprende tutte le operazioni di ricevimento dei materiali, produzione, imballaggio, riconfezionamento, etichettatura, rietichettatura, controllo di qualit�, rilascio, smaltimento e distribuzione delle sostanze attive nonch� eventuali controlli associati. Il termine "Deve" indica le raccomandazioni che ci si aspetta siano seguite, a meno che non si possa dimostrare che non sono applicabili, sono integrate da specifiche linee guida GMP, o sono sostituite da altre misure.

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