Written by: Dr. Wolfgang Pitsch What is your first reaction in the Quality department? Okay… let’s be honest: the first thought is often, “Oh no. This is going to be messy.” But after that initial gut punch, what happens next defines your quality culture. Step 1: Pause and Think The instinct to “fix the number” is strong. Many teams jump straight to retesting because it feels like action. But here’s the question: If the original result had been within specification, would you have rerun the test? No. So why now? Step 2: Understand the Regulatory Expectation Both FDA Guidance for Industry and EudraLex Volume 4, Chapter 6 are clear: The expected next step is not to retest blindly. It is to investigate! A second test without a hypothesis gives you no new knowledge. If the retest passes, it might just reflect natural variation. If you average the two results into compliance, you still don’t know what went wrong with your product or your process. That’s not science—that’s gambling. Step 3:

Marlous van der Hooft In radiopharma, GMP compliance is the baseline. But what truly differentiates high-performing organizations isn’t just adherence to regulations—it’s the ability to embed trust into every layer of the GMP system. At Qualificiency Consulting, we believe GMP should be more than a checklist. It should be a culture of reliability, where systems support processes, and processes empower people. Why Trust Matters in GMP Radiopharmaceuticals operate under extreme constraints: short half-lives, complex logistics, and high regulatory scrutiny. In this environment, trust isn’t optional—it’s operational. Trust enables: Faster decision-making in time-critical production Cross-functional alignment between QA, production, and planning Resilience when deviations or unexpected events occur But trust doesn’t happen by accident. It must be designed into the system. Three Ways We Help Firms Build Trust into GMP Systems 1. Transparency Protocols We help teams implement structured trans

Marlous van der Hooft In radiopharma, what makes a facility truly successful isn’t visible in the walls—it’s in the workflows. The invisible foundation of compliant, efficient, and scalable processes is what determines whether a site thrives or struggles. At Qualificiency, we’ve seen it too often: a facility design is already on paper, sometimes even under construction, and then we’re called in to “make it work.” Retrofitting processes into a pre-defined layout is like trying to choreograph a ballet on a stage built for a rock concert. It costs time, money, and—most critically—compliance. From Engineering to Emotion: A Deeper Understanding of Radiopharma In our previous blog, we explored how radiopharma is more than engineering—it’s emotion, regulation, and precision. The booming theranostics market is full of promise, but also full of pitfalls for those who underestimate the complexity of GMP and radiation safety. What sets Qualificiency apart is not just technical expertise, but live

Understanding Security in Radioprotection Uwe Saathoff Germany’s regulatory landscape for ionizing radiation is comprehensive. It includes the Radiation Protection Act (Strahlenschutzgesetz), the Radiation Protection Ordinance (Strahlenschutzverordnung), DIN standards, and guidance from the Strahlenschutzkommission. These frameworks are designed to protect people and the environment from the harmful effects of radioactive substances. However, most of these regulations focus on safe handling — from procurement and storage to processing and transport. In 2020, a new directive added a layer of security: the SEWD Directive. What Is the SEWD Directive? The SEWD Directive, officially titled “Guideline for Protection Against Interference or Other Third-Party Actions During Handling and Transport of Radioactive Substances”, was issued by the Federal Ministry for the Environment (BMUV). Its purpose is clear: to prevent the criminal release or theft of radioactive materials — either on-site or d

Marlous van der Hooft In 1672, the Netherlands experienced het Rampjaar — the Year of Disaster. The country was attacked from all sides, leadership collapsed, and the people were described as: “Reddeloos, redeloos en radeloos.” Without salvation, without reason, without counsel. This powerful triad captures the essence of systemic breakdown — and it offers a striking metaphor for what can happen in GMP organizations when quality culture is weak or reactive. At Qualificiency Consulting, we often encounter companies where compliance is technically in place, but the culture behind it is fragile. Let’s explore how these three words reflect common pitfalls in quality culture: Reddeloos – Without Salvation When quality systems are overly complex, reactive, or disconnected from daily operations, teams feel overwhelmed. They’re stuck in a loop of deviations, CAPAs, and audits — with no clear path forward. This is what happens when compliance becomes a burden rather than a support structure. Ou

Marlous van der Hooft In GMP environments, performance is often measured by product quality, regulatory compliance, and operational excellence. But what truly drives these outcomes? At Qualificiency Consulting, we believe the answer lies in a deceptively simple formula: (Organisation + Systems) × Culture = Performance This isn’t just a clever equation—it’s a reality we see every day. You can have the most sophisticated systems, the clearest SOPs, and the most robust organizational design. But if the culture is disengaged, fearful, or siloed, those systems will underperform. Culture doesn’t just support performance—it multiplies it. Organisation and Systems: Necessary but Not Sufficient Let’s break it down. The “Organisation + Systems” part includes: Compliance infrastructure: SOPs, CAPAs, audits Organizational design: roles, responsibilities, reporting lines Processes and platforms: digital tools, workflows, documentation systems These are essential. But they are inert without culture.