The U.S. FDA’s push for quality metrics continues to gain momentum. But what does this mean for the future state of pharma?
Data integrity issues have been cited in ever greater numbers by global regulators in both emerging and developed markets. How can companies develop a culture of ethics that prevents this from happening?
As the industry moves away from traditional models of manufacturing, having an effective technology transfer plan will be essential.
Sterile product manufacturing faces divergent expectations from both regulators and compendial guides. How can companies meet these disparate requirements satisfactorily?