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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. 1 US Food and Drug Administration.

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CMC Requirements for New Drug Registration in Latin America

ISPE

This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. Firmino 1 May 2023 The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements.