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The only technical publication dedicated to readers who formulate, manufacture, or package solid dosage forms.

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  • March 5, 2021

NORTH BETHESDA, MD—The International Society for Pharmaceutical Engineering (ISPE) has published the second edition of the ISPE Good Practice Guide: Maintenance, which describes the current established good practices and provides a practical and consistent interpretation of the required elements of a pharmaceutical maintenance program. The updated guide includes consolidated basic and good practices categories, added clarification on terminology, and updated examples. The content of the second edition is aligned with the ICH Q9 risk-based approach with respect to maintenance and the industry as a whole. The guide can be purchased at ispe.org/publications/guidance-documents.