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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

JANUARY 11, 2023

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.

Method Validation 52
Method Validation Documentation Packaging Compounding 52
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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Published July 2014.

Documentation 52
Documentation FDA Communication Packaging 52
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