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ASTM E3106-22

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ASTM E3106-22

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Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
standard by ASTM International, 11/01/2022

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1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs)); all dosage forms; over-the-counter medicinal and neutraceutical products, veterinary products, biologics, clinical supplies, advanced therapy medicinal products (ATPM), medical device manufacturing; and is also applicable to other health, cosmetics, and consumer products.

Product Details

Published:
11/01/2022
Number of Pages:
18
File Size:
1 file , 340 KB
Redline File Size:
2 files , 830 KB
Note:
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