May / June 2020

Features

Annex 2 is the Good Manufacturing Practices (GMP) document by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) addressing manufacture of biological medicinal substances and products for human use. This article shares information about Annex 2 and ISPE’s submitted comments to the draft revision of Annex 2 that was released for public consultation in September 2019.

Insights

Did you know that Women in Pharma® (WIP) has launched a program to initiate Mentor Circles around the globe? While great strides have been made to support women in the workplace, women are still significantly underrepresented in upper management in the pharmaceutical industry. The ISPE Women in Pharma® Mentor Circle program...

Features

On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the...

Insights

Spring is finally here, signaling a time of new beginnings. Today finds me thinking about International Women’s Day (IWD, observed annually on 8 March), a global day of celebrating the social, economic, cultural, and political achievements of women. This year, International Women’s Day has the theme of equality, a very fitting theme for the topics I want to share with you. This issue’s column...