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TOC sampling error could be impacting cleaning verification
Study finds several variables can significantly increase the sampling error in total organic carbon (TOC) swab testing used for pharmaceutical cleaning verification.
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Is plate desiccation impacting microbial monitoring?
New study suggests that Tryptone Soya Agar (TSA) settle plate desiccation during exposure can reduce recovery of airborne microbes.
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Emergent destroyed almost 400mn COVID-19 vaccines due to quality issues, finds report
US Government investigation report suggests Emergent Biosolutions destroyed almost 400 million doses of COVID-19 vaccine and worked to conceal quality issues from the FDA.
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ebook: Early drug development strategies for clinical success
Learn the benefits of collaboration between the pharmaceutical scientists and clinical supply services teams.
webinar
Implementing state of the art technology to characterise polysaccharide vaccines
12 May 2022 | By Bruker
In this on-demand webinar, experts will discuss state of the art technology to characterise polysaccharide vaccines and relative implementation in biopharma development and manufacturing.
whitepaper
Whitepaper: Data integrity and 21CFR.11 for 7000RMS implementation
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
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Could hydrophilins be the key to preventing hospital-acquired infections?
The expression of hydrophilins enables Acinetobacter baumannii to survive without water on hospital surfaces, providing a target for future elimination efforts and a pathway for biologic drug preservation.
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On-demand webinar: Mould contamination, investigation and remediation challenges
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
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Advancing extractables and leachables testing
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
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Should environmental isolates be used in pharmaceutical microbiology?
Are environmental isolates truly beneficial in qualifying microbiological methods? Here EPR summarises Tim Sandle’s recent paper on the debate.
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Quality-driven solutions from discovery to commercialisation
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
whitepaper
Article: Choosing a CDMO for high potent manufacture
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
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How should environmental monitoring locations be chosen?
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
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Guide to Testing
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, discusses the benefits of leveraging acoustic emission testing to identify faults in compressed air pressure vessels, and Associates of Cape Cod and SGS Health Science showcase their services,…
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WuXi Biologics awarded for excellence
WuXi Biologics awarded the Bioprocessing Excellence in Viral Clearance and Safety accolade for the second time at the Asia-Pacific Bioprocessing Excellence Awards (ABEA) 2022 event.
