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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

JANUARY 11, 2023

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. 1 US Food and Drug Administration.

Method Validation

Method Validation Documentation Packaging Compounding

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from.

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Pharmacy Technician Pulse

Life-Cycle Approach to Cleaning Topical Drug Products

CMC Requirements for New Drug Registration in Latin America

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