ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
The 2025 Facilities of the Future Conference will explore innovations in facility design and delivery, emerging trends in technologies, manufacturing, and support areas such as laboratories and warehousing. Also included are the ways technology and digital...
In celebration of International Women’s Month, ISPE Philippines Affiliate hosted an evening of networking dubbed Women in Pharma® Soiree – An Evening of Celebration and Conversation, held 22 March 2024 at the Westgate Filinvest City. The dinner and networking event was organized by the ISPE Philippines Affiliate Women in Pharma® core team led by its Chair, Jayvee Lalusis, MD. The event aligned...
The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is delivering novel treatments for patients and digitized monitoring tools for healthcare professionals; improved operational efficiency, less waste, and resource conservation for industry; and greater connectivity for risk-based regulation.
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved...
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.
The pharmaceutical industry stands at the cusp of a transformative era, where the integration of sustainability within the supply chain is not just a trend, but a necessity. The 2024 ISPE Annual Meeting &...
Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at list price they now make up nearly half of global sales value, a percentage that has been increasing. Many of these are complex products produced in smaller batches for immunology or oncology, and a large majority are biologic therapies, which are generally poorly suited to oral formulations.
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of asset management programs at each company. The initial sessions were a success, covering topics such as asset condition evaluations and asset management governance. CSL was keen to continue the conversations and gather more insights on certain...
Pfizer Asia Pacific Manufacturing Ltd has been honored with the 2024 ISPE Facility of the Year Award (FOYA) Category Award Operations in Project Execution. This prestigious award recognizes the outstanding efforts behind the Pfizer API Facility Extension, commonly referred to as Tuas 2, located in Tuas, Singapore.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...
The ISPE community is saddened by the passing of James (Jim) O'Brien, a founding member of ISPE and a luminary in the field of pharmaceutical engineering. Jim was a recognized expert in the design and engineering of pharmaceutical facilities, whose profound influence has shaped our industry.
Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies. As markets become more familiar with the CTD, especially the quality portion, some drug regulatory agencies are requesting more regional/local documents and customization to CTD documents in accordance with their local interpretation and...
During the COVID-19 pandemic, vaccines were one of the drug products recommended by the World Health Organization (WHO) to fight the pandemic. The majority of regulators have flexed their local regulatory requirements to bring vaccines to the market with as much supply flexibility as possible, including emerging markets which typically have challenging local requirements that a marketing...
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality, on 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal. The...
One of the keynote sessions of the 2024 ISPE Europe Annual Conference held 16-18 April in Lisbon, Portugal was a presentation on EU initiatives to advance digitalization in manufacturing by Evdokia...
