This article is based upon the authors' travels over the last 10 years, looking at aseptic filling operations and seeing what was described to be “a RABS” by the various owners. Some of these are actually amusing, and they illustrate what happens when “hands-on” engineering meets the needs of operations while the compliance department is asleep at the wheel.
The biopharmaceutical industry has unique commercial risks, including complex molecule products, costly supply chain infrastructure that takes a long time to construct, and raw material variations’ impact on process quality and yields.
Cell-based potency assays don’t travel well. Here’s how to make their trip more pleasant from a non-GMP lab to a GMP environment.
FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day.
Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
In pharma outsourcing, RFP templates are a time-saving and efficient tool to initiate and control a bidding process. They allow sponsors to collect comparable proposals that create leverage for negotiation.
This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.
The challenges of comparing conventional colony forming units (CFUs) to newer technologies that are capable of counting individual cells or measuring different variables/factors (such as light, shape, or fluorescence) has limited the acceptance and implementation of new technologies in the pharmaceutical industry.
Packaging artwork is often a forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore. By Stephen McIndoe, VP Consulting, Be4ward
The key to selecting a blender that will blend powders together into uniform mixes, also called "bulk solids," are the material's flow characteristics.
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