How to manage the out-of-service of a GMP equipment step by step
The decommissioning of 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
Closing the cycle: From Risk Analysis (QbD) to Objective Evidence of operation
From healthcare design to documentary evidence In the two previous articles in this series of three technical publications we have
Pharmaceutical architecture, flows and HVAC systems
Where critical deviations are born (or avoided) In the previous article in this series of three technical publications we addressed
Design of pharmaceutical facilities under the QbD paradigm
In the pharmaceutical industry, the design of a facility is neither an architectural exercise nor mere regulatory compliance. Is
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
Risk Management in Aseptic Manufacturing: Practical Application of ICH Q9
Aseptic manufacturing represents one of the most critical environments within the pharmaceutical industry. The absence of a
How the Digital Twin reduces start-up time in pharmaceutical plants by 25%
The pharmaceutical industry faces a historic trilemma: reduce time to market, maintain quality levels