ASTM E2537-16

$29.00

Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
standard by ASTM International, 12/01/2016

Document Format: PDF

Description

1.1 This guide describes Continuous Process Verification as an alternate approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated, and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. Continuous Process Verification (ICH Q8) is similarly described as Continuous Quality Verification.

Product Details

Published:
12/01/2016
Number of Pages:
5
File Size:
1 file , 260 KB
Redline File Size:
2 files , 330 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus

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