Why Large Capital Projects Need a Different Operating Model In large pharmaceutical capital projects, speed is always a priority. But one part of the process still tends to slow everything down: commissioning, qualification and validation. The issue is not expertise. It is the way CQV is still often organised. On complex projects, paper-based workflows, sequential…
When Validation Becomes the Bottleneck Read More »
For years, the question was simple. Do you have a Quality Management System? Procedures written. Deviations logged. CAPAs opened, closed, archived. Everything in place. Then, quietly, the question changed. Does this system actually work? On February 2, 2026, when the FDA’s Quality Management System Regulation (QMSR) comes into force, that nuance becomes decisive. And for
QMSR 2026 – When “Having a QMS” Is no longer enough Read More »
Annex 1 is not a checklist… It’s a system of decisions, and the CCS is its backbone. For years, compliance in sterile manufacturing was often approached as a destination. A milestone reached once the documents were approved, the equipment qualified, and the inspectors satisfied. The 2022 revision of EU/PIC/s GMP Annex 1 changed that paradigm.
Annex 1 is not a checklist Read More »
Once the 3D model is approved, the project leaves the digital world and steps into the real one. What used to exist only on a screen is now standing in a factory, wired, piped, assembled, and ready (in theory) to do the job it was designed for. And this is where things get serious. Because
A Complete Guide to Equipment FAT in GMP and Pharma Projects Read More »
The kitchen Story “A pharmaceutical plant is just like a big kitchen. Our role is to help the client decide what they want to cook, choose the right equipment, install it properly, and show them how to use it. Because buying the right oven doesn’t guarantee a good pizza — you also need the right
Designing a pharmaceutical facility is like designing a kitchen… Here’s Why Read More »
If there is one truth shared across every inspection, whether in the US, Europe, or Asia-Pacific, it’s this: Audit readiness doesn’t depend on how well people repeat procedures. It depends on how well they understand them. Most organisations treat audit preparation as a last-minute exercise: refresh the SOPs, rehearse a few storyboards, tidy up documentation,
Audit Readiness Is Not a Training, It’s a Culture Read More »
Conversations That Matter No deviation’s Takeaways from 2025 ISPE Conference in Singapore Panelists: Dave O’Connor, C&Q Digital Transformation Manager, No deviation, Hazem Eleskandarani, Senior Director, Global Quality Engineering, CSL Behring, Pierre Winnepenninckx, CQV CoP Lead, ISPE Singapore Affiliate & CEO, No deviation, Sebastian Scheler, MD & Chief Methodologist, Innerspace, Yiming Peng, Global Data Science Lead,
Implementing a Risk-based Approach & Benefits and Challenges of Digital Tools Read More »
There’s always that moment—usually around week two of a greenfield project—when someone gets starry-eyed and says, “What if we just let AI write the protocols?” Cue the collective nods. Cue the excitement. Cue… the same old paper-based FAT, SAT, and Excel punch list. Let’s be honest: AI-generated anything sounds sexy. But in our world—where a
AI, Punch Lists & GMP Dreams: Notes from the (Digital) Field Read More »
Conversations That Matter No deviation’s Takeaways from 2025 ISPE Europe Annual Conference in London Speakers: Alice Redmond – CAI, Kevin O’Donnell – Health Products Regulatory Authority (HPRA), Graham Carroll – MHRA, Arie Menachem – Novo Nordisk ICH Q9 isn’t new. Even the revision (R1) is no longer fresh off the press. But the conversations it sparks
Conversations That Matter No deviation’s Takeaways from 2025 ISPE Europe Annual Conference in London Speaker: Dr. Evdokia Korakianiti – Head of the Quality and Safety Department at the European Medicines Agency (EMA) At this year’s ISPE Europe Annual Meeting, Dr. Evdokia Korakianiti delivered a timely message: we are at a unique regulatory inflection point in Europe—one
Building a Smarter Regulatory Future: Innovation, Access, and the Fight Against AMR Read More »
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