Periodic requalifications in GMP: how to maintain the validated state of equipment and systems
Requalification (often called periodic qualification) is a fundamental pillar in GMP regulations. In simple terms: It is not enough to […]
The Digital Product Passport (DPP): innovation and compliance in GMP environments
In the pharmaceutical industry, traceability is not an option: it is a critical requirement. However, the new Digital Passport
GAMP® 5: The Quality Strategy for Computerized Systems
In the era of Industry 4.0, digital transformation in the regulated sector is no longer an advantage
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
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.
Technical guide. Pharmaceutical water systems 2026: Digitalization, sustainability and regulatory update
Water is one of the most relevant critical services in the pharmaceutical industry. Its transversal use (from the formulation
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
From perpetual pilot to productive system: industrialize with AI in process plants
Over the last decade, artificial intelligence in the process industry has gone through a phase of experimental enthusiasm characterized