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ASTM E2898
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Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Published by | Publication Date | Number of Pages |
ASTM | 06/01/2020 | 7 |
ASTM E2898 – Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
1.1 This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.
Product Details
- Published:
- 06/01/2020
- Number of Pages:
- 7
- File Size:
- 1 file , 110 KB
- Redline File Size:
- 2 files , 220 KB
- Note:
- This product is unavailable in Russia, Ukraine, Belarus