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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

JANUARY 11, 2023

The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. Often referred to as the validation stage, stage two: qualification confirms that the cleaning procedure under normal conditions meets preestablished acceptance criteria. January 2011. Guidance for Industry.”

Method Validation 52
Method Validation Documentation Packaging Compounding 52
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CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.

Documentation 52
Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52
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