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...

From guidance on how to define temperature and humidity requirements and cleanroom design in pharmaceutical and biotechnology facilities to chemistry, manufacturing, and controls (CMC) requirements for new drugs in Latin America and evolving regulatory requirements in China, the top read

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...

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.

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.

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,...

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.

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...

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...

It is not surprising that there are regulations and guidance specifically for ATMPs. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines with the ATMP sector not always clear on the regulatory expectations. A session at the 2025 ISPE Europe Annual Meeting in May 2025, presented by Jon Halling, Managing Director for...