ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are suggested summer reading ideas—articles on important topics from recent issues to revisit when you have some down time this summer—or to enjoy for the first time in case you missed them. Learn more about knowledge management implementation, zero carbon, MES, and more.
ISPE’s second virtual Global Pharmaceutical Regulatory Summit, held on 16 June 2021, brought together regulators from European Medicines Agency (EMA), Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration, and Center for Drug Regulation and Research, FDA Philippines to share their insights on application of quality risk management. They discussed the positive...
The San Francisco Bay Area Chapter has won numerous ISPE Awards by virtue of their contributions to the pharmaceutical industry. They continue to have their finger on the pulse of the local industry and respond with innovative and educational programs. The Chapter’s Emerging Leaders Committee is especially active and plans monthly events while also helping new graduates become successful in...
The life sciences industry is experiencing a real estate gold rush. Already prosperous, pre-pandemic, life sciences construction surged dramatically when the COVID-19 vaccines rapidly expanded the need for administrative, research and development, and manufacturing spaces in the biotechnology field. This has led to a vast expansion in medical and biotech construction that has not abated, even...
Vaccine Manufacturing Innovation
Awareness of the pharmaceutical industry has increased significantly in the last 15 months due to the global pandemic. Vaccine manufacturing is now in the spotlight more than ever before. The issues of production output, supply chain shortages, and cold chain distribution have been discussed in mainstream media and are now commonly...
The past year has been unprecedented for the manner in which the world’s population has adapted to living with the changes brought about by COVID. The life sciences sector has always been to the fore at unleashing scientific innovation to make life better for humanity, and that creativity went into overdrive as the industry pivoted to meet those challenges.
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
COVID-19 has caused disruptions and delays with supply chain all across the world. Single-Use technologies (SUT) play a vital role in manufacturing of pandemic vaccines and have drastically reduced the typical vaccine development and manufacturing production timelines. The pandemic has further increased the sourcing demands for SUT. This non-forecasted demand has led to extended lead times or...
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are suggested summer reading ideas—articles on important topics from recent issues to revisit when you have some down time this summer—or to enjoy for the first time in case you missed them. Learn more about knowledge management implementation, zero carbon, MES, and more.
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.1
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
