Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.
The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.
The life sciences industry and academic world seem to produce incredible scientific breakthroughs on a daily, if not hourly, basis these days. The pace of scientific breakthrough is mesmerizing, as a dazzling variety of technologies and studies have helped humans understand the underlying causes of disease. Whether those causes are genetic, environmental, or behavioral, it seems that we have an arsenal of tools to understand much more than ever how we can meet unmet human health needs.
Many people in our industry have had root cause analysis (RCA) training. It is aimed at helping people understand an issue and the underlying reasons it happened. Once you have those reasons (the “root causes”), you can act on them. This is the most effective way of trying to stop the same issue from recurring. And RCA is now a requirement for serious issues per ICH E6 (R2).
Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.
In Oct. 2019, the FDA’s Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report’s findings and discusses potential next steps the FDA may take.
When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?
This article presents the most recent publication of GMP drug inspection data from CDER, published November 15, 2019 and addressing drug inspections conducted in FY2019. We’ll also take a look at seven years’ worth of trends in drug GMP inspections.
A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.
Part 1 of this series provided an overview of continued process verification (CPV) and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing.In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.