2011, Method Validation and Packaging - Pharmacy Technician Pulse

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2011

Method Validation

Packaging

Life-Cycle Approach to Cleaning Topical Drug Products

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. Process Validation: General Principles and Practices.

Method Validation

Method Validation Documentation Packaging Compounding

CMC Requirements for New Drug Registration in Latin America

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.

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Life-Cycle Approach to Cleaning Topical Drug Products

CMC Requirements for New Drug Registration in Latin America

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