Validation

3 articles tagged “Validation”

USP Pharmaceutical Water Revisions Official on 1 April 2027: Who Is Affected and How to Prepare

19 Oct 2026

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.

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.

JOB in Pharma

26 Nov 2020

Pharmaceutical Industry contributes to improving the health and wellbeing of society.