In a June 25, 2026 notice on data integrity in medical devices, the FDA takes note of “an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical […]
If you’re seeing the same deviations pop up (gowning fibers in the dryer room, unexplained assay drift after solvent changeover, or audit trails with gaps, for example), then it’s not necessarily a “people performance problem“ alone. Rather, it may suggest that depth in the root-cause analysis (RCA) within the investigation process may also be an […]
On April 29, 2026, the FDA published a notice in the Federal Register (FR) (posted on the FR prepublication page (here)) announcing the FDA’s intention to withdraw approval of the New Drug Application (NDA) for TAVNEOS (avacopan) capsule, 10 milligrams (mg), held by ChemoCentryx, Inc. and offer the applicant an Opportunity for a Hearing regarding the FDA’s […]
The second day of the Generic Drugs Forum provided a significant amount of new and rehashed data, including explanations and suggestions regarding certain application submission issues, including but certainly not limited to DMFs, data integrity and the ongoing nitrosamine saga. Here are a few of the helpful hints presented: When providing amendments to DMF, the […]
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 […]
