ISPE

MAY 9, 2023

ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 29, 2022

Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies.

Documentation 52

Documentation FDA Communication Packaging 52

The FDA Law Blog

FEBRUARY 13, 2025

The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Additionally, a failure is NOT considered unresolvable if a root cause analysis of the failure reveals it is not related to specific aspects of the PCCP. In such cases, performance testing may be conducted again.

FDA 71

FDA Documentation Labelling Method Validation 71