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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

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52
Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52
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