ASTM E2475 – Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
1.1Â 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 ICHâQ8). 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
- Note:
- This product is unavailable in Russia Ukraine Belarus