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Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
Dr Vladimir Makarov, AI Community lead, The Pistoia Alliance, explains that despite the willingness of the life sciences R&D industry to adopt artificial intelligence (AI), data integrity is a key area that must be addressed to ensure successful integration of this fast-evolving technology.
18 December 2024 | By MasterControl
This webinar explores the major trends impacting life sciences in 2025 and how the pharma industry can capitalise on the latest developments shaping quality management.
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
9 December 2024 | By European Pharmaceutical Review
During this virtual panel, industry experts will explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products…
IMA Pharma discusses approaches to keeping Amoxicillin and Clavulanic Acid tablets stable and effective by addressing moisture sensitivity and preventing degradation.
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
The innovative method uses spectroscopy and could enhance pharmaceutical quality assurance in resource-limited settings, the study suggests.
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
By automating and simplifying hydration of media, feeds and buffers, the Oceo Rover system enables manufacturers of biopharmaceuticals to improve process consistency and speed time-to-market. Here, Guy Matthews, Director of Single-Use Technology for FUJIFILM Irvine Scientific, shares more about this transformative hydration solution.
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
This application note explores rapid microbial methods and balancing patient care, quality products, and safe shelf lives for unique formulations.
In this Guide to Outsourcing article, Jessica Rayser, Associate Director Product Management, Accugenix®, explores how outsourcing microbial identification can benefit technicians and facilitate the most accurate identification possible.
Regulatory inspections can be challenging, but proper preparation turns them into opportunities for improvement and compliance demonstration.
