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 […]
In the FDA-regulated industry, speaking up is a cornerstone of a mature quality culture. It refers to the reporting of deviations, risks, concerns, or unethical practices, whether related to product development, manufacturing, data integrity, or patient safety. When embedded in an organization, speaking up inherently increases detection of signals that are directly or indirectly indicators […]
Digital resilience is a concept that often needs to be revised and redefined within an organization. The pharmaceutical industry can be slow at times to identify potential external risks and assess the potential impact to operations. Much of the work we do here at Lachman helps regulated industry anticipate and mitigate Quality Management System risks […]
Have You Used These Terms Before: Monitoring, Governance, Auditing? Are they the same? Are they different? Are they related in some cryptic way, but you find it difficult to explain? Can anyone execute them? Do they require different skill sets? Understanding the differences between these roles is essential for professionals working in regulated environments, such […]
Congratulations! Your firm has just successfully manufactured a high-quality pharmaceutical or biological product and is ready to ship it to the next destination to get it into the hands of the people who need it. Take a moment… is your firm REALLY ready? Your firm’s product is either starting its journey in a global supply […]
