iSpeak Blog
A technical working group under ISPE’s PQLI® Committee that is seeking to assist industry and regulators with implementation of ICH Q12 recently produced a webinar on
iSpeak Blog
Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant within the law and regulatory guidelines. All this is influenced by...
iSpeak Blog
For as long as I can remember, I have always felt I was different. However, I have never felt it more than when I was in foreign countries, interacting with people from all over the world. These were some of my most life-changing experiences, and I have ISPE to thank for that, with it being such a diverse and inclusive community. I must admit that there were moments where I was uncomfortable –...
iSpeak Blog
At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, two international regulators and a senior representative from industry discussed current and future collaboration between industry and regulatory authorities.
iSpeak Blog
During 2020, the pressure points of the COVID-19 pandemic challenged us to broaden our thinking and change our practices. Adjustments were made at a global scale and more people were immersed in the experience of dealing with a crisis than ever before. This generated a spotlight on pharmaceutical supply chain practices. Patients and regulators were increasingly asking: what are best practices...