In the global business environment, advancements in technology and digital platforms are changing how business operations are being carried out. The big data explosion has ensured that business and the digital platform become synonymous to enhance the productivity and efficiency of businesses.

John Clarke works with Pfizer in Dublin, Ireland and is currently the Process Lead on a facility expansion project for conjugate vaccine manufacture. John graduated from University College Cork with a Bachelor of Science in Microbiology and earned a Masters of Engineering Science in Biopharmaceutical Engineering from University College Dublin and has held roles across Quality, Validation, and...

What a year to be agile for collaboration and innovation! Our industry has been driving unprecedented success for patients this year, which is fitting for the 2021 ISPE Annual Meeting & Expo theme, “Agility. Collaboration. Innovation.”

Heating, Ventilation, and Air Conditioning (HVAC) systems are critical systems that can affect the ability of a pharmaceutical facility to meet its objective of providing safe and effective products to patients. In this iSpeak blog post, we talk with leading expert Norman Goldschmidt, President, Genesis AEC, on some HVAC FAQs.

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

There are two different sides of confidence which I would like to discuss here: the idea of confidence in the workplace and confidence in oneself. 

The issue of data integrity may appear archaic in a highly connected, digital world. Yet many within the pharmaceutical industry it continues – be it intentional or not – to fall foul of regulators tasked with auditing businesses’ practices. Peter Cusworth at Yokogawa examines an age-old problem, its importance, and why organisations continue to get it wrong.

The wait is over… The 2021 ISPE Annual Meeting & Expo is back and will be held in Boston, Massachusetts, at the Hynes Convention Center and Sheraton hotel from 31 October–3 November. This year’s...

Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during May 2021. Learn more about cleanliness classifications for facilities, steam sterilization, GAMP®, and more from what visitors to the PE Online site were reading last month

I am excited to share with you that the first “Face to Face” ISPE Conference since the beginning of COVID-19 is now scheduled to take place in North Bethesda, Maryland, USA, on 1–2 February. The

Thomas Hartman, ISPE’s President & CEO and active ISPE Member for over 20 years, speaks with us on his favorite ISPE memories, his real-world examples on the benefits of ISPE, and why volunteering is so important. Join us as we get to know Thomas a little more.

Dr. Randy Perez retired from the position of Director of Information Governance and Management for Novartis Pharmaceuticals in 2015. During his 32-year tenure at Novartis his responsibilities included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oaxley, and data privacy. He served on several global teams dealing with computer systems compliance issues and authored many of the...

ISPE continues to work with a group of industry associations to assist the European Union (EU) and the European Medicines Agency (EMA) with implementation of revision of Annex 1, Manufacture of Sterile Products....

This virtual ISPE Global Pharmaceutical Regulatory Summit, held on 28 April 2021, brought together eleven regulators from different parts of the world to discuss how their approach to GMP inspections have adapted to the COVID-19 pandemic. Such a large number of regulators at a single forum is unprecedented for ISPE.

As a young Science graduate, I couldn’t think of anything worse than being stuck at the same desk, day in / day out, in a stuffy office, doing the same thing day after day, just to earn a living. There had to be more to life, right? I wanted to travel the world, see new places, not be defined by what I do or how I look, and most definitely not be pigeonholed due to my career choice or hair...

The main change can be seen on the imports of IMPs from EU/EEA to Great Britain starting 01 January 2022. Sponsors of United Kingdom Clinical trials will need to appoint a United Kingdom Manufacture & Importation Authorization (MIA) (IMP) holder who will be responsible for implementing an oversight process to confirm each batch has been certified by a Qualified Person before its release to...

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

While Pharmaceutical development and manufacturing have focused for years on robust quality management systems (QMS), the application of quality risk management (QRM) applying digital tools and advances are critical to future success. Coupling controls, artificial intelligence, and associated platforms with basic QMS and QRM affords a great opportunity for the pharmaceutical industry.

Case studies demonstrating the link between knowledge and risk in technology transfer and commercial manufacture

Economic Operators Registration and Identification (EORI) Number

Customs procedures also imply having an Importer of Record liable at destination as well as having each party, exporter, and importer, registered, and identified with its own EORI (from the Country it is based at). An XI EORI number is required to move goods between NI and non-EU Countries (which comprise Great...