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.

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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 52

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Reader note: This article was initially submitted to Pharmaceutical Engineering® during December 2021/January 2022.

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