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ISPE QC/Analytical Community of Practice Established

ISPE

The Steering Committee meets monthly to discuss QC-specific topics and to update progress towards knowledge sharing projects ( ISPE Guides , Pharmaceutical Engineering ® Magazine articles, ISPE Training , etc.).

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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification.

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CMC Requirements for New Drug Registration in Latin America

ISPE

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.