Virtually every ISPE member has at least one story to tell about how health authority inspections or the review and approval of regulatory applications have affected their efforts to supply critically needed medications to patients globally. Although these stories may emphasize the considerable...
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...
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...
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...
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...
