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 quality by design (QbD) (Juran, 1992;2 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.
Product Details
Published:
09/01/2016
Number of Pages:
7
File Size:
1 file , 150 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
