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.
This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to ensure faster approval of biosimilars.
Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement.
The stated mandate of the regulatory authorities (such as the FDA) and pharmacopeias (such as USP) is that they establish and monitor safety, efficacy, and quality of the manufactured drug products that patients need. It is important to note that at the manufacturing stage, safety and efficacy are seldom – in fact, almost never – established and/or measured. Establishing the quality of the manufactured products acts as a surrogate for the safety and efficacy; hence, claims are always limited to the quality aspect.
Sampling plans are used extensively throughout organizations regulated by the FDA. Most organizations have a statistical procedure that specifies a certain acceptable quality level (AQL) based on risk. (If not, they should!) However, most individuals just follow the requirements of the procedure without fully comprehending how sampling plans actually work.