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Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
STANDARD published on 15.4.2010
Designation standards: ASTM E2475-10
Note: WITHDRAWN
Publication date standards: 15.4.2010
SKU: NS-45390
The number of pages: 7
Approximate weight : 21 g (0.05 lbs)
Country: American technical standard
Category: Technical standards 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; 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: |
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