ASTM E2475-23

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

Published by Publication Date Number of Pages
ASTM 2023 7
Category Industry

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ASTM E2475 – Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran 1992;2 ICH Q8). The framework is applicable to both drug substance (DS) and 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 continual process improvement efforts.

Product Details

Published:
11/15/2023
Number of Pages:
7
File Size:
1 file 440 KB
Redline File Size:
2 files 660 KB
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