News

When Risk Management Plans Ignore Australian Context.

Carl Bufe

Published on: 08/02/2026

What happens when Risk Management Plans treat Australian patients as European by default? The safety implications of inadequate local adaptation.

pharmacovigilance

A Starter Guide to GMP Annex 22

Carl Bufe

Published on: 20/10/2025

GMP Annex 22 sets new rules for AI in pharma manufacturing, linking with Annex 11 and Chapter 4 to define validation, data governance, and inspector expectations for compliant, explainable, and risk-based AI use in GMP environments.

AI in Manufacturing