Every now and then, a shift in technology revolutionizes an entire industry. Consider the advent of email and automatic banking machines. Once the mainstream adopts these processes, it is difficult to imagine how we managed without them. By Valdo Arnera, MD, General Manager of PHT Corporation Europe
A company has to be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.
This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations.
This article explains the final three components that can be used to establish a compliant disinfectant efficacy testing package in the U.S. along with tips for assembling the package.
This article summarizes opinions on how well specific regulations have impacted operations and looks at the general health of some key quality management system (QMS) elements that are described and proposed in these regulations.
In the cold chain logistics industry there’s a huge change happening. Lots of data is being gathered by wirelessly connected data loggers, sensors and monitoring equipment. By Nitin Dahad, Dyzle
The FDA publishes data on Form 483 inspection observations and warning letters issued by the Center for Drug Evaluation and Research (CDER) during the previous fiscal year. By analyzing this annual data pharmaceutical and biopharmaceutical manufacturers can gain a clearer picture of FDA enforcement trends and their potential impact on business.
While the ability to ship drugs to sites on the surface appears to be simple, failures to meet demand occur, in my view, far too often.
The supply chain problems highlighted most frequently include lack of coordination, inventory management, absent demand information, human resource dependency, order management, shortage avoidance, expiration, warehouse management, temperature control, and shipment visibility.
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