Audit

3 articles tagged “Audit”

Revised Schedule M: The Inspection Can Come Any Day. Is Your Site Ready?

27 Sept 2026

The revised Schedule M is the standard your next inspection will be run against. Which Parts apply to your licence, what is built once for the whole site, what blocks what, and what an inspector asks for in the first four hours.

ISO 9001:2026: What Actually Changed, and What You Already Owed

20 Sept 2026

ISO 9001:2026 is published and the transition runs to September 2029. What is genuinely new, what was already required before this edition, and what it means if you also work to GMP.

Pharmaceutical Documentation: Hierarchy, Types & GMP Rules

24 Dec 2020

You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.