Communication, FDA and Method Validation - Pharmacy Technician Pulse

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Communication

FDA

Method Validation

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

Documentation

Documentation FDA Communication Packaging

CMC Requirements for New Drug Registration in Latin America

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

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

CMC Requirements for New Drug Registration in Latin America

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