Norm

ASTM E2475 - 10 en

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

  • Deze norm is ingetrokken sinds 01-09-2016

50,60 61,23 Incl BTW

Over deze norm

Status Ingetrokken
Aantal pagina's 7
Gepubliceerd op 15-04-2010
Taal Engels

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; FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.

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:

Details

ICS-code 11.120.01
Engelse titel Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
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