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European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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Data integrity
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The hidden costs of microbial misidentifications
20 April 2023 | By Charles River Laboratories
Doug Botkin, PhD, examines the challenges and consequences of inaccurate microbial identification methods using real-world case studies and discusses how these challenges can be addressed.
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Prioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
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Overcoming barriers to capturing data in a laboratory
A key issue faced in pharmaceutical laboratories is the integration and standardisation of data from the array of instruments. Here, Samantha Kanza from the University of Southampton outlines some challenges with using laboratory information management systems or other digital tools. How might these be overcome?
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Endotoxin trends: sustainability, automation and beyond
In this Q&A Miriam Guest, Principal Microbiologist at AstraZeneca UK, discusses trends in bacterial endotoxin testing, as well as factors to consider when looking to implement rapid methods.
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Video: Understanding current regulatory thinking on contamination control strategy
Virtual seminar presented by Ziva Abraham, President, and CEO of Microrite designed to improve your understanding on current regulatory thinking on designing an effective contamination control strategy.
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Case study: Expedite microbial contamination investigations
Find out how rapid microbial monitoring can help mitigate lengthy contamination investigations by identifying the root cause of high plate counts.
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Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
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GAMP 5 update: computerized system expectations for pharma manufacturers
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
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Whitepaper: LIMS integration: overcoming the hurdle of microbial QC digitalization
Learn how automated microbial enumeration technologies can ensure seamless integration of LIMS, improving lab efficiency and data integrity.
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Case study: Reduce plate counting costs and delays
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
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An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
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NICE partners with health technology assessment bodies
Five health technology assessment (HTA) bodies will collaborate with NICE to help resolve regulatory and digital health technology challenges.
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On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
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Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
