ASTM E2537

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 , 73 KB

Redline File Size:

2 files , 150 KB

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