If GMP already accommodates AI, the next challenge is practical execution. The goal is not to “add AI compliance,” but to embed AI into existing quality systems with intent and discipline. Part 2 of this series (here) unconsciously introduced the often-misunderstood concept of “critical thinking,” which is easy to say, but difficult to perform in […]
The prevailing industry narrative around artificial intelligence (AI) governance often presumes that we are entering fundamentally uncharted regulatory territory—territory that will necessitate entirely new compliance architectures. The recent FDA–EMA guidance “Guiding Principles of Good AI Practice” suggests otherwise. It reinforces a more pragmatic conclusion: the existing global GMP framework already provides the structural foundation necessary for […]
Overview of Regulatory Alignment The recent joint FDA–EMA guidance “Guiding Principles of Good AI Practice in Drug Development” has sparked conversation across the industry. Do you view it as a major shift or dismiss it as “just another guidance”? The truth usually sits between those extremes. This blog series will examine the signals, which we […]
Since their introduction to the public in 1979, spreadsheets have come a long way. Even while technology has changed, from Apple II computers to artificial intelligence, spreadsheets have had incredible staying power. Nevertheless, spreadsheets struggle to keep pace with GxP requirements. In regulated companies, required to adhere to GxPs, spreadsheets can be useful, but they are […]
The global pharmaceutical industry is undergoing a significant transformation. Driven by supply chain resilience, regulatory incentives, and geopolitical considerations, many companies are onshoring manufacturing operations, bringing them back to domestic soil. While this shift may have a perceived promise of improved security and faster delivery of critical medicines, it also introduces the invisible risk of […]
Why Using Full-Scale Deflection Introduces Data Integrity Risks In pharmaceutical manufacturing, Accuracy is a critical ALCOA+ principle that can sometimes get lost, particularly when assessing the holistic system. The field instrument level needs to be adequately integrated into the overall assessment, especially in aseptic manufacturing environments where sterilization is critical (and accurate data, such as […]
The concepts of Speak Up and Quality Culture have received renewed attention with recent developments of the European Union’s Artificial Intelligence Act. Lachman recently blogged about the importance of a healthy quality culture (Speak Up! Does Your Quality Culture Have a Voice?), and new proposals under the Digital Omnibus package in the EU introduce three […]
The life-sciences industry has long been synonymous with high barriers to entry. Traditional research and development (R&D) models demand enormous capital investment, specialized infrastructure, and a deep understanding of regulatory compliance. For startups and innovators, these requirements often translate into years of fundraising and risk before a single product reaches the market. However, the emergence […]
The effect of publicly stated economic strategies cannot be overstated. These strategies drive the direction of the global life-science ecosystem. Good companies utilize Quality Risk Management (QRM) practices to integrate them into company-specific strategies. Great companies transform them into the proverbial competitive advantage, ensuring the right drug, at the right time, to the right patient. […]
This blog is another in a series providing an analysis of legislative initiatives that may impact your business. Q4 is the time of year when many pharmaceutical companies scan the horizon and develop their enterprise risk assessments and mitigation plans, which should trigger a review of these initiatives. The Economic Crime and Corporate Transparency Act […]
