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Web portal: Check your elemental impurity according to ICH Q3D guidelines
Request your Proficiency Testing (PT) samples to ensure your elemental impurity analysis is compliant with ICH Q3D guideline or any other ICP analysis.
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Global mass spectrometry market to value $7.3 billion by 2028
With roughly a fifth of the mass spectrometry market made up by pharma and biotech, growing R&D investment and technological breakthroughs in mass spectrometers will contribute to market growth.
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Cell-based seasonal influenza vaccine safe and effective in children
Phase III data shows Seqirus’ cell-based quadrivalent seasonal influenza vaccine was as effective and safe as an equivalent FDA-approved egg-based vaccine in paediatric patients.
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ISPE announces its manufacturing Facility of the Year Awards winners
The awardees, including Takeda, Janssen and Gilead, are recognised for their state-of-the-art facility design, construction and operation projects.
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Global pharmacovigilance market to value almost $15bn by 2028
Research suggests outsourcing and the increasing incidence of adverse drug reactions (ADR) will be primary drivers of growth in the global pharmacovigilance market.
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Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
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Trends to watch out for in the pharmaceutical robot market
EPR’s Hannah Balfour summarises a market research report exploring trends in the pharmaceutical robot market between 2021 and 2028.
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Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
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Is the compendia-recommended microorganism test panel truly representative?
A recently published paper suggests the test panel of microorganisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.
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Balancing regulations for weighing in a GMP quality control laboratory
The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
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Product hub: How can you ensure product quality if you are not in control of your manufacturing environment?
Without confidence in your environmental monitoring (EM) data and microbiological testing, you can never be completely sure that your products are free from unwanted microorganisms. Our Accugenix® microbial identification and strain typing services offer unparalleled accuracy that you can rely on.
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Nelson Labs: supporting internal quality processes
Nelson Labs is the leading global extractables and leachables lab testing platform, in this guide find out about their other services and how, from development to delivery, they can help get your products to market.
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QA/QC & Analytical Techniques In-Depth Focus 2021
In this in-depth focus, discover why testing for heavy metal contaminants in cannabis vaping aerosols is a pressing need, how using trending charts to monitor inventory movements could benefit pharma, the regulatory requirements for analytical balances operating in GMP and GLP laboratories and the different HPLC methods available for oligonucleotide analysis.
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Measurement of heavy metals in cannabis vaping aerosols: a practical assessment
In light of the increased popularity of cannabis vaping in the United States, new regulations in the state of Colorado assert the need to test for heavy metal contaminants. Here, Robert Thomas explains the reasons for this pressing need and the challenges it presents.
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Sourcing of key excipients
The course of drug development rarely does run smooth. Here, Dave Elder considers how sourcing key excipients impacts the process, highlighting potential consequences of a dual sourcing strategy and suggesting how to approach problems of inter-supplier variability.
