When new technology takes the industry by storm, does your QA team have the “education, training, and experience” necessary to execute their required responsibilities? Even when outsourced, the contract giver needs to have the requisite skills to provide adequate oversight. These concepts are also summarized in the FDA publication “Q10 Pharmaceutical Quality System” regarding both […]
Provision of healthcare is a key topic globally with increasing populations worldwide, increasing healthcare system costs, multiple humanitarian crises, and supply chain concerns. Two weeks ago in Dublin, Medicines for Europe brought together industry leaders and experts to discuss better access to medicines in hopes of addressing at least some these issues. Generic medicines play […]
In the realm of pharmaceuticals, navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change. When faced with regulatory scrutiny, it is imperative for companies to not only address the identified issues but also to comprehensively understand the root causes […]
No, please don’t. Environmental Monitoring (EM) program is not a “one size fits all” package. Rather, it should be customized to a particular manufacturing space and the processes used after a robust risk assessment that considers potential failure modes and then followed up, periodically evaluating past EM data. If you were to do an internet […]
I think we would all agree that the above saying very much applies to addressing any issues with the health of any firm’s Quality Management System. It is far less painful when your own Quality Oversight (QO) system self-identifies events rather than having them pointed out by a regulator during a health agency inspection, which […]
Now, don’t get too excited as this likely will not apply to you (see below for more detail for non-small dispensers)! The FDA expects all entities to be fully compliant with the Drug Supply Chain Security Act (DSCSA) by November 27, 2024; however, there are certain exemptions for what the Agency describes as “small dispensers” that […]
Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]
It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]
Forget the cadence of the traditional three-to-five-year business plan when it comes to Artificial Intelligence (AI). The pace of change in this environment has indicators that need to be followed on a quarter-by-quarter basis. In Q1, we wrote about the fast evolving environment both from the legal perspective and the regulatory aspect in blogs that […]
A review of recent Form 483s and Warning Letters shows that investigations continue to be a focus of FDA inspections, where the following citation is commonly issued: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether […]
