ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
The importance of the 2024 ISPE Europe Annual Conference is evident with the continuous challenges the pharmaceutical industry is facing in terms of drug shortages, regulatory requirements, digitalization, automation, and big data management.
It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...
At the 2023 ISPE Pharma 4.0™ and Annex 1 Conference, held 11 – 12 December 2023 in Barcelona, Spain, a panel discussion that included regulators from around the world, as well as industry experts,...
Carla J. Lundi, US Food and Drug Administration (FDA) Senior Consumer Safety Officer, Division of Quality Intelligence II, FDA, presented the regulatory keynote at the 2024 ISPE Facilities of the Future...
Artificial Intelligence (AI) can be described as the application of computer science, statistics, and engineering, utilizing digital algorithms or models to analyze information, perform tasks and exhibit behaviors such as learning, making decisions, and making predictions.
One of the keynote sessions of the 2023 ISPE Pharma 4.0TM and Annex 1 Conference held 11 - 12 December 2023 in Barcelona, Spain was a presentation on European Union (EU) initiatives to...
The energy in the room was palpable as attendees eagerly awaited the start of what promised to be an enlightening and thought-provoking evening.
ISPE’s Regulatory Quality Harmonization Committee (RQHC) is structured with four Regional Focus Groups (RFGs): Asia-Pacific, Europe/Middle East/Africa, Latin America, and North America. The RFGs support ISPE in its understanding and response to regulatory issues and concerns for the specific region. The RQHC Asia-Pacific RFG includes pharmaceutical professionals located in or having specific...
Aaron Bober is an active member of ISPE, the ISPE Women in Pharma® Boston Chapter, and the ISPE Women in Pharma International Steering Committee. He is based in the Boston, Massachusetts, area and serves as the Director of Engineering, New England, at IPS. Bober developed the below testimonial, recounting his personal experience and investment in supporting women in the pharmaceutical industry...
With well over a century of history and change, the first International Women's Day was held in March 1911. International Women's Day is a day of collective global activism and celebration that belongs to all those committed to forging women's equality.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...
ISPE’s Women in Pharma® community prides itself on endorsing equal opportunity for equal effort. Through global and regional programming, the community creates opportunities to shift company cultures and mindsets to create a more inclusive and equitable industry, where diversity of thought thrives.
Annex 1 has been in effect since August 2023. But what has been its impact? This topic will be discussed at the 2024 ISPE Aseptic Conference in Vienna, Austria and virtually. Speakers from both industry and...
ISPE members came together to ask questions about ISPE Communities of Practice (CoPs) in a live session hosted by Tim Postlethwaite, Director of Technical Communities with ISPE, and Anna Riley, Member Operations Manager with ISPE.
In 2020, CSL Behring (CSL) initiated a benchmarking activity with a small group of peer companies identified through ISPE and the members of the ISPE Supply Chain, Operations, and Packaging (SCOPE) Community of Practice (CoP) Steering Committee to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset...
The 2024 ISPE Facilities of the Future Conference will be held on January 29-30, 2024, in San Francisco, CA, USA, and virtually. This conference brings together pharmaceutical industry stakeholders,...
