Data Integrity in hybrid systems: good practices for paper and electronic systems
Digitalization is advancing steadily in the pharmaceutical industry, but operational reality shows that many organizations continue to work […]
Equipment qualifications and systems validations
Implementing quality: risks, changes and validation in pharmaceutical projects
Many technically correct pharmaceutical projects end up generating deviations, delays in qualification or difficulties in inspection for a common reason:
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
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.
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.