Mergers and acquisitions in the pharmaceutical industry are nothing new. CDMO consolidation has become prevalent over the last several years as well. More recently, however, a new and more complex dynamic has emerged: pharmaceutical companies acquiring CDMOs outright. A pharmaceutical company acquiring a CDMO represents more than financial consolidation. It fundamentally reshapes the quality, compliance, […]
A firm can face a situation in which it needs to engage a third party, and this may be encouraged or required in order to address a health-agency regulatory citation. For example, consider the following language from an FDA Warning Letter (WL): “Based upon the nature of the violations we identified at your firm, you […]
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 […]
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 […]
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 process of debarment began after the generic drug scandal in the late 1980s and the FDA continues to use this process to preclude individuals from participating in a variety of activities, including drug development, manufacture, clinical studies in support of drug applications, and importing drugs into this country if they are have been convicted […]
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 […]
With a new U.S. administration and leadership at HHS, regulatory priorities have evolved over the course of 2025. While the exact current and potential future priorities of the FDA may not be fully known at this point, one can expect continued focus on compliance, product quality, and supply-chain resilience, making it crucial for pharmaceutical and […]
