iSpeak Blog
ISPE is pleased to announce the complete Advancing Pharmaceutical Quality Program (APQ) Program is now available with the release of the fifth and final guide.
iSpeak Blog
By the ISPE Regulatory Team
ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. Support for that mission was on display at the 2022 ISPE Annual Meeting and...
iSpeak Blog
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin, Ireland on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium was titled “Thriving at 50 and Striving Forward” and was aimed at promoting and...
iSpeak Blog
As we are all aware, the COVID-19 pandemic has had a unique, world-wide effect on the pharmaceutical industry as well as health authorities. At the height of the pandemic, and continuing as it appears to wane, health authorities have not been able not carry out normal, in-person inspections of pharmaceutical manufacturing sites. However, in the ”Age of Covid,” using the Internet and associated...
iSpeak Blog
ISPE Aseptic is one of those conferences where the depth of knowledge astounds me. When I started attending and speaking at the ISPE Aseptic Conference in the 2000s, I came to grow and learn.
iSpeak Blog
The 2022 ISPE Singapore Affiliate Conference & Exhibition featured a regulatory roundtable discussion on the Future of Pharmaceutical Inspections.
iSpeak Blog
On 17 August 2022, four international regulators discussed how the Covid-19 pandemic had taught regulators to look for alternative ways of doing GMP inspections and also to rely more on each other to make determinations on the GMP status of manufacturers of medicines.
iSpeak Blog