£82.35

Annexe 1-2022 de l'EU-GMP pour la production stérile avec conseils et explications: Les directives s'appliquent aux PIC et à la FDA

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Last 72 days · 72 data points (no recent data)

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£82.35 £78.23 £79.88 £81.53 £83.17 £84.82 £86.47 09 July 2026 26 July 2026 13 August 2026 31 August 2026 18 September 2026

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72 days 0 18 36 54 72 £82 Days at Price

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Most common price: £82 (72 days, 100.0%)

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Price levels: 1 different prices over 72 days

Description

Afin de répondre aux exigences techniques des lignes directrices GMP de l'UE, l'EMA publiera ces lignes directrices récemment mises à jour en 2022 en tant que nouvelle annexe 1 des GMP de l'UE pour la fabrication de produits stériles/aseptiques. La nouvelle annexe 1 des GMP de l'UE est très complète par rapport à l'ancienne annexe et comprend 11 chapitres et 59 pages, y compris un glossaire. L'ancienne annexe 1 ne comptait que 16 pages. Le chapitre 8 contient à lui seul 139 points pour la production et les technologies spécifiques. Afin de comprendre les textes et exigences complexes de cette nouvelle annexe 1, une explication technique a été incluse dans la deuxième colonne de ce livre en plus du texte original en anglais. Ces explications contiennent des informations pratiques issues d'années d'expérience dans la production et la gestion de la qualité. Ce livre contient également un dictionnaire complet sur l'ingénierie pharmaceutique.

Product Specifications

Format
paperback
Domain
Amazon UK
Release Date
28 November 2024
Listed Since
29 November 2024

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