iSpeak Blog
Late last month, ISPE published the 2nd Edition of the ISPE Good Practice Guide: Good Engineering Practice. This revision comes a decade and a half after the original guide was...
iSpeak Blog
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are popular articles that visitors to the site were reading during October. Revisit articles on cleanliness classifications, steam sterilization, pharma water systems, and more.
iSpeak Blog
ISPE’s Facility of the Year Awards (FOYA) celebrates cutting-edge engineering, new technology, and unique collaborations. It provides a platform for the pharmaceutical science and manufacturing industry to showcase...
iSpeak Blog
Over the past twenty years, an evolution of pharmaceutical development has resulted in new approaches to ensuring product quality and patient safety. The science and risk-based concepts outlined in ICH Q8-Q12 encourage a more holistic approach to the product control strategy. Under this paradigm, product quality should not be ensured by the quality specification, rather it should be confirmed....
iSpeak Blog
Since the FDA issued final guidance on Data Integrity in 2018, the challenges have been many. The growth in observations has been substantial. With IT transforming dramatically over the last...
iSpeak Blog
The final session of the 2021 ISPE Annual Meeting & Expo was the Global Regulatory Town Hall. It brought together regulators from around the world to provide insights about current issues including harmonization and convergence. This year’s panel session was heavily flavored by inputs about lessons learned by regulators during the pandemic, and what may change (or not) after pandemic.
iSpeak Blog
The Membership and Awards Breakfast at the 2021 ISPE Annual Meeting & Expo on 2 November saw the traditional passing of the gavel in person for the first time in two years as Jörg...
iSpeak Blog
The theme of the 2021 Annual Meeting & Expo is agility, collaboration, and innovation, and these were demonstrated from a number of perspectives in the keynote presentations during the...