4 articles tagged “Audit”
USP <1231> has been revised and the monographs for Water for Injection, Pure Steam and the sterile waters now allow a recombinant endotoxin test. Official on 1 April 2027: what changed, which dosage forms it touches, and a six-month roadmap.
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 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.
You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.
