iSpeak Blog
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ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
iSpeak Blog
ISPE Podcast: Shaping the Future of Pharma has published an episode featuring Gunter Baumgartner, Senior Vice President, Head of Global Engineering at Takeda Pharmaceuticals International AG and...
iSpeak Blog
Johnson & Johnson Innovative Medicine, part of the Johnson & Johnson family of companies, develops innovative and integrated products and medicines to restore and extend the quality of life for patients globally. The expansion of Johnson & Johnson’s BioCork facility in Ringaskiddy, Cork, Ireland increased the existing biomanufacturing capacity at the plant while also creating...
iSpeak Blog
Already in the 1980s and 1990s, environmental labelling programs emerged as a way to guide consumers toward greener choices. These third-party “seal-of-approval” systems—like the European Communities Eco-labelling Program (Regulation (EC) No 66/2010 – EUR-Lex), the Nordic Countries program, and the national programs of Canada, France, Germany, Austria, the Netherlands, Singapore, New Zealand, and...
iSpeak Blog
iSpeak Blog
You won't want to miss the 2025 ISPE Annual Meeting & Expo in Charlotte, North Carolina, USA 26–29 October. This isn’t just another industry gathering; it’s where our community challenges assumptions, learns from each other, and shapes the future...
iSpeak Blog
Johnson & Johnson’s facility in Latina, Italy, is a small molecule manufacturing site for global launches and commercial supply of solid dosage forms. It is also the strategic launch and growth site for manufacturing and packaging of solids products. Johnson & Johnson Latina site’s diverse portfolio includes multiple therapeutic areas.
iSpeak Blog
Allyssa Wilcox is a Sourcing Manager for Site Operations Procurement at AstraZeneca. She is an ISPE member and is also a member of the ISPE Chesapeake Bay Area Chapter and ISPE’s Women in Pharma®. In this interview, Wilcox delves into her ISPE membership experience, volunteer activities with ISPE, sources of inspiration, what trend excites her most in the industry, and more.
iSpeak Blog
Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes including cleaning and sterilizing equipment, laboratory activities, and as an ingredient. The systems that generate and distribute pharmaceutical water and steam are subject to C&Q and/or verification to ensure that they will consistently deliver water and steam that meets regulatory,...
iSpeak Blog
Written by a global team of pharmaceutical sustainability experts, the ISPE Sustainability Guide presents key principles and concepts to reinforce sustainable practices in the pharmaceutical industry, based on global and local guides, including existing regulations. “We had a very diverse group of authors from pharmaceutical companies of all sizes and consulting groups who wrote the Guide. The...
iSpeak Blog
Cleanroom garments are worn by operators working in certified cleanrooms to protect the product and the processes inside the cleanroom from human sourced contamination and to maintain the integrity of the cleanroom. Selection and correct use of these garments has a significant impact on the performance of the cleanroom, an appropriate selection allows the use of lower air change rates as the...
iSpeak Blog
According to the Organ Procurement and Transplant Network (OPTN), every 10 minutes, one new person joins the organ recipient waiting list. As of the end of June 2025, more than 100,000 were on OPTN’s waiting list in the US. Traditionally, FOYA winning facilities are focused on the manufacturing of clinical or commercial products and research lab facilities enabling discovery of medicine.
iSpeak Blog
ISPE released the ISPE Good Practice Guide: Digital Validation in April 2025. Guide Leads Mark Drinan of Takeda Pharmaceuticals International AG, Phil Jarvis of Grifols, and David O’Connor of No Deviation presented an overview of the Guide at the 2025 ISPE Europe Annual Conference in May, in their session “Digital Validation Mastery: Enabling Validation 4.0.” Watch their presentation below.
iSpeak Blog
ISPE members represent a rich and diverse source of expertise for improving regulation and guidance documents. Through its commenting activity, ISPE leverages this expertise for maximum benefit to industry, regulators and patients.
iSpeak Blog
As a leading innovator and manufacturer, Erbe Elektromedizin GmbH specializes in the development and production of advanced surgical systems. Erbe stands at the forefront of medical technology innovation, providing significant benefits to patients through minimally invasive surgical solutions tailored to the needs of customers.
iSpeak Blog
At the 2025 ISPE China Conference in Shanghai, China in May 2025, Marcus Ray, Medical Products Supervisor at the US Food and Drug Administration’s (US FDA) China Office, delivered a comprehensive update on the agency’s regulatory and inspectional activities. His presentation, titled “FDA Regulatory and Inspection Updates,” offered a detailed look at the FDA’s evolving global strategy, with a...
iSpeak Blog
Regulators from the European Medicines Agency (EMA), the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA), and the Austrian Agency for Health and Food Safety (AGES) addressed the rapidly evolving landscape of pharmaceutical regulation in the digital age on 14 May at the 2025 ISPE Europe Annual Conference in London, UK. The panel discussed key areas shaping the...
iSpeak Blog
The United States Pharmacopeia (USP) has long set standards for the use of plastics in medical devices for implantation and packaging. The biotech industry has adopted these standards so efficiently that it is ingrained in every product containing a plastic exposed to a biotech process.