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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. For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. Chapter 10 in Madsen, R., Moldenhauer (eds.)

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

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. Published July 2014. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,