Potrebujeme váš súhlas na využitie jednotlivých dát, aby sa vám okrem iného mohli ukazovať informácie týkajúce sa vašich záujmov. Súhlas udelíte kliknutím na tlačidlo „OK“.
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
NORMA vydaná dňa 1.9.2016
Označenie normy: ASTM E2475-10(2016)
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.9.2016
Kód tovaru: NS-650886
Počet strán: 7
Približná hmotnosť: 21 g (0.05 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Keywords:
control, pharmaceutical manufacture, process understanding,, ICS Number Code 11.120.01 (Pharmaceutics in general)
1. Scope | ||||||||||||||
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992;1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. |
||||||||||||||
2. Referenced Documents | ||||||||||||||
|
Posledná aktualizácia: 2024-04-29 (Počet položiek: 2 896 215)
© Copyright 2024 NORMSERVIS s.r.o.