All Data integrity articles – Page 3
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NewsRegulatory revision essential for bioprocess IIoT adoption
A limited number of Industrial Internet of Things (IIoT) applications exist in the bioprocessing industry and remain to be challenged in manufacturing operations, research has highlighted.
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NewsEuropean regulators prepare for AI in pharma
A coordinated workplan, which runs to 2028 will help European regulators embrace opportunities for artificial intelligence.
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ArticleNitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
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News'Innovation-first' mindset vital for advanced therapies sector future
Improving data harmonisation and investing in the advanced therapy sector’s workforce are some of the key recommendations the sector must take to advance the field and increase patient access, a new report highlights.
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ArticleEmbracing automation in sterile manufacturing
Krishna Venkatesh, Global Head Sterile Operations at Dr Reddy's Laboratories discusses how and why the pharma industry is embracing automation.
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Whitepaper
Scientific journal: Complete your clinical research 6 to 9 weeks faster
Discover how completing your trials in Canada can accelerate your early phase clinical research by six to nine weeks compared to an IND submission.
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Webinar
How to implement single temperature incubation in your environmental monitoring routine
Watch this webinar to hear Laurent Leblanc explore the challenges and benefits of implementing the “one media / one temperature” approach for routine environmental monitoring.
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Whitepaper
ebook: Accelerate the development of your biologics
Altasciences’ Proactive Drug Development can accelerate the development of biologics by up to 40%, from lead identification to clinical POC.
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ArticleConsiderations for safety data migration methods
Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade. In this article, ICON’s Graeme Bones explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.
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NewsAchieving pharmaceutical drug traceability compliance
A paper has highlighted a technology system for achieving drug traceability compliance and help prevent production of counterfeit drugs.
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ArticleUncovering new frontiers in microbiology and EM
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
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ArticleLeveraging PAT for environmental monitoring in light of Annex 1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from ...
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ArticleEuropean Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
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WhitepaperReport: Accelerate the RMM validation process
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
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Webinar
Advantages of automated microbial colony counting
Watch this webinar with independent microbiology expert Dr Tim Sandle to explore the different technologies, regulatory concerns and validation requirements for automated colony counting methods.
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ArticleDigitalising HPLC methods: the path to interoperability
Transferring analytical methods between companies is often a challenging, time-consuming manual process. In this Q&A, Dr Birthe Nielsen, Project Lead at The Pistoia Alliance, speaks about an ongoing project to digitally transfer HPLC data between different vendors.
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Whitepaperebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
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Whitepaperebook: Accelerate the development of your small molecule
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
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Video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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ArticleGuide to Data Integrity
Welcome to EPR's Guide to Data Integrity. In this edition, Charles River explores the significance of data integrity in pharmaceutical manufacturing, Graeme Bones of ICON considers how to complete database transfer with data integrity considerations at the forefront and Rapid Micro Biosystems® discusses the practical implications of the ‘four-eyes principle’ ...
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