Navigating GMP & GDP standards: Quality Assurance and process-centered design in pharma & biotech.
WHO put a redrafted quality risk management guideline out for comment on 18 September 2026. Comments close 15 November. The structure barely moved; the work is in what was added. Here is what is new, where it comes fr...
Jaap Koster
CEO / Senior GxP Consultant
What the Post Office Horizon scandal should make every pharma professional ask about their own suppliers.
Jaap Koster
CEO / Senior GxP Consultant
The sneaky thing about heat is that it never feels like what it's doing to you. You feel a bit tired, a bit done with the day. You don't feel the extra mistakes. But they're there.
Jaap Koster
CEO / Senior GxP Consultant
In November 2025 the FDA spent two weeks inside a Greek sterile-injectables plant and left nine observations behind. Six months later the site was under an Import Alert, two products had been recalled, and US producti...
Jaap Koster
CEO / Senior GxP Consultant
The EMA has opened a pilot project assessing pharmaceutical quality system effectiveness at manufacturing sites, with inspections running through March 2027. The specific focus: whether your change control process act...
Jaap Koster
CEO / Senior GxP Consultant
In this post, we discuss five FDA topics from 2026 that are relevant (particularly) to QA and regulatory affairs in the US market.
Jaap Koster
CEO / Senior GxP Consultant
A supervisor who understands why a cleaning validation protocol exists will explain it differently to their team than one who just knows it's required. That shows up six months later as fewer repeat deviations. A QA o...
Jaap Koster
CEO / Senior GxP Consultant
ICH Q3E addresses a real concern. Patients deserve safe products, and understanding what leaches from plastic materials is part of that. Nobody disputes the principle. But a guideline whose cost and complexity fall di...
Jaap Koster
CEO / Senior GxP Consultant
For over 35 years, PCS Academy has been training professionals in the pharmaceutical industry. What started in 1991 has grown into a training programme that has educated more than 10,000 GxP professionals — with an av...
Jaap Koster
CEO / Senior GxP Consultant
In GMP environments, the concept of Quality by Design (QbD) is usually discussed in the context of product and process development. Guidance documents consistently emphasize the importance of properly designed premise...
Jaap Koster
CEO / Senior GxP Consultant
he rules that govern the manufacture, import and distribution (a.o.) of medicine consist of a relationship between binding EU legislation, practical guidance, and national (“local”) medicines law that actually powers...
Jaap Koster
CEO / Senior GxP Consultant
“You can’t call it a planned deviation. That’s an oxymoron.” The phrase is usually followed by a name-drop. An inspector said it. A consultant insisted on it. A colleague heard it in an audit debrief. Someone “high up...
Jaap Koster
CEO / Senior GxP Consultant
ALCOA++ is often encountered at the most inconvenient times: during an investigation, audit, or meeting when the question pops up that seems to be the simplest of all: “Who did this, and when?”
Jaap Koster
CEO / Senior GxP Consultant
Too often we find ourselves in discussions with QA teams. The topics are often simple, for example: the standards of manufacturing science—common in any serious manufacturing environment outside pharma—also apply to p...
Jaap Koster
CEO / Senior GxP Consultant
The consultation follows several COVID-19 legal flexibilities in the Human Medicines Regulations 2012 (HMRs) that helped deliver vaccination programmes at scale, and some of those provisions are time-limited and due t...
Jaap Koster
CEO / Senior GxP Consultant
Increasingly, more Dutch transport companies transport medicinal products and want to have a GDP certificate to reassure their customers that they have implemented measures to safeguard quality and safety.
Jaap Koster
CEO / Senior GxP Consultant
For manufacturers and distributors of medicinal products, this is more relevant than it may seem. The document more clearly defines who drafts, who reviews, how broadly changes are scoped, how comments are handled, an...
Jaap Koster
CEO / Senior GxP Consultant
The U.S. FDA published the final version of a Guidance for Industry on conducting remote regulatory assessments in June of 2025. Remote Regulatory Assessments (or in short: RRA's) were utilized during the COVID-19 pan...
Jaap Koster
CEO / Senior GxP Consultant
During recent MES/IT vendor demos for a “paper‑less” pharmaceutical factory, something stood out: No one mapped or discussed data‑flow and data‑risk end‑to‑end, despite years of regulatory focus on data governance. Ev...
Jaap Koster
CEO / Senior GxP Consultant
Ignoring pests just because you haven't visibly noticed them yet is certainly not a strategy—especially when compliance and product safety are on the line.
Jaap Koster
CEO / Senior GxP Consultant
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