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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
October 18, 2024
Redica Systems has been assisting pharmaceutical companies in determining GMP quality risks at their manufacturing sites, and with AI, it has a relatively new addition to its toolbox.
The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.
The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.
October 11, 2024
The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.
October 10, 2024
Various microorganisms, including molds and bacterial spores, were tested on stainless-steel coupons and demonstrated 2–6 log reductions with one-minute wet-contact times.
October 09, 2024
Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan.
October 08, 2024
Andrew Lewis, PhD, Chief Scientific Officer, Quotient Sciences, discussed the CMC challenges with GLP-1 and oral peptides during CPHI Milan.
Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.
October 02, 2024
Substituting a compendial-grade material with a food-grade material is not acceptable, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
The use of artificial intelligence and machine learning has the potential to provide some key benefits; however, there are still significant barriers to the implementation of these advanced technologies.