Taking a potential drug from candidate selection through clinical development and eventual commercialization is a challenging process. It is not a question of if something unexpected will happen, but when. And when the inevitable problem occurs, how will your CDMO tackle this situation?
This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).
Guideline on the Quality Requirements for Drug-Device Combinations (EU) and Principles of Premarket Pathways for Combination Products (U.S.) are the latest attempts to regulate combination products. Here, we examine the two guidances in detail, beginning with the U.S. regulatory guidance.
Proposals for the use of visual inspection (VI) as an analytical method for cleaning validation have been rising for several years now. This article recommends the use of statistical techniques, and suggests how VI could be implemented as part of a strategy in a cleaning validation program based on risk level.
Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!
As technology advances and experimentation with existing approved entities broadens, the use of “combinations” will continue, and the proper use of them will depend on regulatory professionals reminding development teams of the differences as data becomes available.
With an increasing number of pharmaceutical plants having been in service for decades, the topic of aging facilities has become a major concern for regulatory agencies. And rightfully so — aging facilities can contribute to quality issues and drug shortages, among other problems. But what exactly is an aging facility?
There exist far fewer pediatric devices than adult devices on the market, meaning one of the most vulnerable patient populations also is one of the most underserved.
Lack of proper training remains a systemic problem. However, proper training can ensure that employees integrate quality and agency requirements into everyday activities.
For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”
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