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...
