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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

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Resolution RDC 10/2011. Published 24 March 2011.

Documentation 52
Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52
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