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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

Validation of Cleaning Processes (7/93): Guide to Inspections Validation of Cleaning Processes.” August 2014. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. Bethesda, MD: PDA and River Grove, IL: DHI Publishing, 2014. January 2012.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Published July 2014. As part of the change management process, personnel must manually find, view, and interpret the older data sets to establish a frame of reference for completing method validation exercises and compare the initial and optimized assays. Lo Surdo, J., Cauchon, C. Ramdas, and E. Zavialov. “A 5 (2021).