Articles

Although travel continues to be reduced or restricted across the world, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual conference and virtual executive...

Then and Now – From Certainty to Discovery Mindsets Advancement in technologies have forced organisations to rethink business models. Organisations that were once controlled and orderly are now more chaotic and complex, serving patients and customers...

Our story started in October 2018 when I met a colleague at a conference and we had no time even to share our news: we were always in a hurry, only able to discuss business. The pharmaceutical industry is unique in its stability: many people who come...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

Wow! As a Founding Member of ISPE, you’ve been with the Society for 40 years! Can you provide a brief summary of your involvement with ISPE and share some of the more interesting experiences and successes you’ve had with the Society during your lengthy...

Graziella A. Molinari In December 2019, the ISPE Italy Affiliate devoted its annual “ISPE Italy Christmas Night” to Women in Pharma® and unveiled a new...

This blog is the last of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...

We have all been given a lot of options lately. Google “things to do in quarantine” and you will have your pick from a slew of categories. With all these workout videos -- where to start? Which book to read? Make the trending Degong coffee or join my...

This blog is the third of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...

There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system...

This blog is the second of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

2020 ISPE Biopharmaceutical Manufacturing Virtual Conference ISPE’s first virtual conference, the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference, is a new format for delivering education, information, and networking—a fitting first virtual meeting for ISPE given the cutting edge...

This blog is the first of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...

Our Young Professionals (YPs) community has been growing over the last couple of years and we are working hard building Young Professionals groups within European Affiliates. In this edition of ISPE Update, we would like to put the spotlight on all the...

James P. Agalloco President As ISPE celebrates the 40th anniversary of its establishment, we would like to recognize those members that have been with...

The topic of continuous manufacturing has drawn considerable interest across all modalities of pharmaceutical manufacturing. Thus far much of the progress has been seen in small molecule drug product manufacturing platforms where multiple products have...

The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations...

Example case studies show how the evolution of advanced analytics enables innovation in pharma.

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfers the knowledge to a different...

When we first launched the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in 2017, we benefited from an incredible enthusiasm and engagement from across the ecosystem. At the time, academic institutions were working to...