The recent bankruptcy announcement of 23andMe is a classic case study in data ownership – not necessarily what should happen, but what actually does happen! Open and transparent discussion about data ownership is sometimes easier if the situation is not strictly a GxP issue, but the learnings and analogies in a QMS or PQS should […]
On October 26, 2020, a business plan was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that eventually resulted in a holistic revision to ICH Q9, “Quality Risk Management,” the “R1” of the framework. The four areas of concern were identified as: High levels of subjectivity in risk assessments […]
On March 11, 2025, the EU formally proposed a regulation to not only fight drug shortages but also to maintain its status as a global leader in the production of pharmaceutical products. We have previously published a blog that identified the convergence of U.S. and EU efforts that can be found here. While the U.S. navigates […]
Since 1976, the International GMP Conference has been co-sponsored by the University of Georgia College of Pharmacy and the U.S. Food & Drug Administration. However, this year, through no fault of the Agency, the FDA was unable to attend. This was unfortunate (to say the least), especially as this public-private collaboration amongst a number of […]
How is your company reacting to threats in its supply chain and transforming risk into opportunity? In a mature application of Quality Risk Management (QRM), companies should lean into the political winds of “onshoring,” “nearshoring,” and “friendshoring” as these concepts have been stood up as well-discussed risk mitigations to the current drug shortage problems. These […]
Whether you believe synthetic data to be real or fake, the overall market for it is expected to grow from $351.2 million in 2023 to $2,339.8 million by 2030 (Synthetic Data Generation Market Forecast | Fortune Business Insights). This statistic can make the most hardened cynic’s ears perk up. But, surely, in our world of regulated medicinal […]
Lachman Consultants has continued its active engagement with efforts to combat the global drug supply chain shortages. Despite the FDA’s significant success in helping to prevent 236 drug shortages in 2023, the problem persists and may be about to get worse. The current problem, external environment, and emerging risks are highlighted in a recent publication […]
Day 2 of the 2024 PDA/FDA Joint Regulatory Conference kicked off in a similar format to Day 1 with a panel discussion, moderated by Andrew Hopkins, that delivered key messages from various FDA leaders. An explanation of the imminent changes in the Agency’s organizational structure (CBER, CDER, and CVM) dominated the conversation. However, an impactful response from […]
U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
A couple of months ago, when we returned from Barcelona to San Francisco, it was impossible to check in online for some reason. Then the news broke about flight disruptions due to the CrowdStrike software update! Some flights, including ours, were only a couple of hours delayed. However, many more passengers were affected even further […]
