news
ICH to implement M14 Guideline for post-marketing safety submissions
The ICH Assembly’s decision supports progress in promoting international standards for safety assessment of medicines.
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QA/QC
news
In-line pharma monitoring system developed for tablet quality inspection
The novel approach could enhance quality testing applications in pharmaceutical manufacturing.
webinar
The Future of Sterility Testing: One-Day Results with Advanced RT-rt PCR Technology
2 September 2025 | By FUJIFILM Wako Europe GmbH
Join this webinar to find out how RT-rt PCR is revolutionising sterility testing and discover a unique approach that provides reliable one-day results and enhanced sensitivity and detection capabilities.
news
Pharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
news
FDA starts publishing daily adverse event data
US regulator says the move to open up the FAERS database will help modernise its safety monitoring.
webinar
Mastering Impurity Profiling: USP’s Evolving Standards and Strategies
22 August 2025 | By US Pharmacopeia
Join our live webinar with USP as they explore new approaches for impurity profiling - unveiling new frameworks, analytical tools, and regulatory insights that are reshaping pharmaceutical quality standards.
news
ICH opens consultation on Q3E drug impurities guideline on leachables
Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
news
AI driving automated microbiological testing market growth to 2033
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
article
Advancing endotoxin testing with sustainable recombinant LAL solutions
The pharmaceutical industry faces mounting pressure to modernise its testing methods, driven by concerns over animal welfare, sustainability, and the need for more reliable results. Following a recent webinar, Fujifilm Wako discusses its Pyrostar™ Neo+ reagent and reveals how recombinant technology is transforming endotoxin testing while addressing evolving industry demands.
article
Supporting the pharmaceutical industry – how a CDMO can help
After their recent webinar, European Pharmaceutical Review’s Head of Content Ian Betteridge spoke with the team at Adragos Pharma to discuss the role of a CDMO and their importance in the fill and finish sector.
article
A rapid microbiological method case study for advanced therapy medicinal products
In this article, Stacey Ramsey, Senior Manager – Microbial Applications Lab, Charles River Laboratories, discusses the modernisation of rapid microbiological methods (RMMs) and the potential of ATP-bioluminescence when testing cell-based products.
news
Sandoz breaks ground on new European biosimilar plant
The new investment will help Sandoz to expand its European biosimilar manufacturing capacity and ensure reliable and sustainable supply in the region.
webinar
Harnessing AI to transform quality and manufacturing in life sciences
2 July 2025 | By MasterControl
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
webinar
Lipid formulations in softgels – enhancing bioavailability and therapeutic efficacy
27 June 2025 | By Thermo Fisher Scientific
This webinar will explore how lipid formulations in softgels can enhance drug absorption and bioavailability.
article
Guide to Testing 2025
In this Guide to Testing, articles explore method validation for endotoxin testing and using advanced chromatography solutions for analytical laboratory applications.
