ISPE

JANUARY 11, 2023

For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. 11 (2017): 36–46. 10 Rivera, E.,

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Method Validation Documentation Packaging Compounding 52

ISPE

MAY 9, 2023

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. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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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. BioProcess International 15 (September 2017):24–47. Published July 2017. Macheras, and K. Tschorn, U.

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