A technical working group under ISPE’s PQLI® Committee that is seeking to assist industry and regulators with implementation of ICH Q12 recently produced a webinar on

Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant within the law and regulatory guidelines. All this is influenced by...

For as long as I can remember, I have always felt I was different. However, I have never felt it more than when I was in foreign countries, interacting with people from all over the world. These were some of my most life-changing experiences, and I have ISPE to thank for that, with it being such a diverse and inclusive community. I must admit that there were moments where I was uncomfortable –...

At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, two international regulators and a senior representative from industry discussed current and future collaboration between industry and regulatory authorities.

During 2020, the pressure points of the COVID-19 pandemic challenged us to broaden our thinking and change our practices. Adjustments were made at a global scale and more people were immersed in the experience of dealing with a crisis than ever before. This generated a spotlight on pharmaceutical supply chain practices. Patients and regulators were increasingly asking: what are best practices...

At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, four international regulators discussed how regulatory authorities and industry were responding to the COVID-19 pandemic crisis.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

The New ISPE Discussion Paper, “Unique Identification on Primary Containers to Drive Product Traceability & Quality” explores how container traceability...

Over more than two decades, the pharmaceutical industry has increasingly adopted single-use technologies primarily to simplify manufacturing while hoping to reduce cost; however, the need to reduce environmental burden continues to have a huge impact on these operations. As a member of the 2021 ISPE Aseptic Conference Program Committee I am privileged to be leading the session titled:...

Teresa Minero has served as ISPE Italy Affiliate Chair, Vice-Chair, and as a leader of the Affiliate’s Student and Women-in-Pharma Groups. An ISPE Member for more than 26 years, she is currently a member of the ISPE Board of Directors. The Founder and CEO of her own company, LifeBee, Teresa has numerous accomplishments,...

What is accountability? By definition, “it is taking or being assigned responsibilities for something that you have done or something that you are supposed to do.” We can take this far beyond that. Accountability means doing what we say we will do, always, on time and to the best of our ability. It means setting goals and achieving them. It means consideration of others, saying yes to things...

The 2021 ISPE Aseptic Conference is your key to unlocking success – success in personal technical growth, success in a robust project execution, and success for continuous operation and improvement. I have said for...

The ISPE APQ Assess, Aspire, Act and Advance Framework will be complemented with an OPEX Benchmarking and ICH Q10 maturity assessment tool specifically developed for use with the APQ program by the University of St.Gallen, Switzerland. Used in conjunction with the APQ self-assessment tools for quality management maturity, the pre- and post- benchmarking activities offer objective evidence of...

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

As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe...

Lou Kennedy, Nephron Pharmaceuticals’ President & CEO and active ISPE Member, was recently honored with a 2020 Business Leader and Public Servant of the Year Award. We spoke with Lou to learn more about her company, the many initiatives she and Nephron are undertaking on behalf of pharma, Nephron’s community, and how women are making a difference in the industry.

The 2021 ISPE Aseptic Conference 30th Anniversary will be held on 15 – 17 March offering attendees several unique perspectives and case studies across two separate tracks. For many years, the ISPE Aseptic Conference...

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

It is time to celebrate the 30th anniversary of the ISPE Aseptic Conference at the 2021 ISPE Aseptic Conference. Hard to believe, isn’t it?

The Life Sciences industries adhere to strict documentation practices to prove quality and compliance. We’re all familiar with the truism “If it isn’t written down, it didn’t happen.”

FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to the pandemic have been combined with FDA knowledge from prior public health crises to...