Impact of the Annex 15 revision on manufacturers
In the previous article we analyzed what changes Annex 15 brings and what key message the inspectors are sending, as well […]
Equipment qualifications and systems validations
GMP Annex 15 is currently under review
Annex 15 – Qualification and Validation is one of the classic pillars of European GMP and, precisely because
The new EMA GMP inspection plan until 2028: when supervision becomes a strategy
In January 2026, the new GMP/GDP Inspectors Working Group (GMDP IWG) work plan came into effect.
How to manage the out-of-service of a GMP equipment step by step
Decommissioning GMP (Good Manufacturing Practices) equipment is the formal and documented process for removing equipment.
7 elements that a Maintenance Plan must include to preserve the qualification status
In the pharmaceutical industry, maintenance is not only a technical function aimed at the availability of assets. It's a
Avoid late deviations: how to correctly structure DQ, FAT and SAT
In the development of new facilities, manufacturing lines, automated systems or critical equipment in regulated environments, delays and
Why is risk key in the validation of automated systems?
In the pharmaceutical industry, automated control systems are the basis for the safe, efficient and reproducible operation of products.
GMP requirements for the qualification of water systems in pharmaceutical environments
In the pharmaceutical industry, water is one of the most critical services. Used as raw material, solvent, agent
PLC validation in pharmaceutical processes
In the pharmaceutical industry, where precision, safety and regulatory compliance are the main pillars, logical controllers
Vapor and purified water distribution systems in pharmaceutical facilities: design, qualification and regulatory compliance
In the pharmaceutical industry, critical services distribution systems such as pure steam (Pure Steam), purified water