Many technically correct pharmaceutical projects end up generating deviations, delays in qualification or difficulties in inspection for a common reason:
In the pharmaceutical sector, quality is not an attribute added at the end of the project; It is a structural condition that
Requalification (often called periodic qualification) is a fundamental pillar in GMP regulations. In simple terms: It is not enough to
In the pharmaceutical industry, traceability is not an option: it is a critical requirement. However, the new Digital Passport
In the era of Industry 4.0, digital transformation in the regulated sector is no longer an advantage
In the previous article we analyzed what changes Annex 15 brings and what key message the inspectors are sending, as well
Annex 15 – Qualification and Validation is one of the classic pillars of European GMP and, precisely because
In January 2026, the new GMP/GDP Inspectors Working Group (GMDP IWG) work plan came into effect.
Decommissioning GMP (Good Manufacturing Practices) equipment is the formal and documented process for removing equipment.
