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iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 – Materials and Components
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. Use of the optimum gowning reduces particle shedding and can allow the use of...
Good Practice Guide: Validation 4.0
iSpeak Blog
Validation 4.0 for the Pharmaceutical Industry

The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain. Validation 4.0 ensures that validation processes are not a bottleneck but a strategic enabler of innovation, quality, and compliance by embracing artificial intelligence (AI), Internet of Things...

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iSpeak Blog
Balancing Speed and Quality in the Construction of Pharmaceutical Facilities

The pharmaceutical industry is no stranger to innovation. From pioneering drug development to advanced manufacturing processes, it thrives on new ideas. But when it comes to construction, particularly the delivery of critical infrastructure such as laboratories, cleanrooms, and research facilities, many companies in the sector still rely on traditional building methods.

Shanghai
iSpeak Blog
Igniting Innovation in the East: Reflections on ISPE’s Launch in China
As I approach the six-month mark in my role as President and CEO of ISPE, I’ve been inspired by the energy and commitment of our global community. One of the most meaningful experiences so far was from a recent visit to Shanghai, China, for the 2025 ISPE China Conference hosted by the ISPE China Office—an event that marked the official restart of ISPE’s presence in China.
Vivien Santillan
iSpeak Blog
ISPE Women in Pharma® Update: Q1–Q2 2025 Activities
As Chair of ISPE’s Women in Pharma® International Steering Committee, I am proud to share a dynamic midyear update on the incredible momentum we have built together throughout 2025. This year has been marked by transformative progress, reinforcing our role as a driving force on leadership connection, and innovation across the global pharmaceutical community.
EU25-Attendees
iSpeak Blog
Workforce of the Future – Challenges and Opportunities
The recent “Workforce of the Future – Challenges and Opportunities” session at the 2025 ISPE Europe Annual Conference brought together professionals from across the pharmaceutical, biotech, and engineering sectors for a dynamic and thought-provoking conversation on the evolving nature of the workforce. The energy in the room remained high throughout the session—a testament to the commitment and...
Ian Jackson - EU2025
iSpeak Blog
Regulatory Innovation and Global Collaboration highlighted at the ISPE Europe Annual Conference
On the opening morning of the 2025 ISPE Europe Annual Conference in London, United Kingdom, Ian Jackson offered an inside look at the PIC/S, a collaboration of 56 health authorities that works to harmonize GMP standards and inspections. Jackson is an expert GMP inspector with the Medicines and Healthcare products Regulatory Agency (MHRA) and is eligible to be named as a Qualified Person (QP).
Chugai Pharmaceutical Manufacturing Co
iSpeak Blog
A Visit to 中外製薬工業株式会社 Chugai’s Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence
In late May, I had the distinct pleasure of visiting 中外製薬工業株式会社 Chugai Pharmaceutical Manufacturing Co., Ltd.’s UK4 biological drug substance manufacturing facility in Tokyo, Japan—Category Winner of the 2024 ISPE Facility of the Year Awards (FOYA) in Social Impact. This visit was not only inspiring but also a powerful reminder of the innovation and dedication that define the future of...
Navigating the Horizon
iSpeak Blog
Navigating the Horizon: ISPE’s Vision for Tomorrow
For centuries, explorers have scanned the horizon in search of opportunity and clarity. At ISPE, we carry forward that spirit of discovery as we look to the future of pharmaceutical science and manufacturing.
standard-quality-control-collage-concept
iSpeak Blog
When Analytics Meet Quality
In today’s data-driven world, the quality management paradigm in the biotech industry has transcended traditional methodologies, embracing advanced analytics and emerging technologies to redefine efficiency, precision, and speed to market. The adoption of machine learning, predictive analytics, and big data has revolutionized quality management, enabling companies to address complex challenges...
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