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Whitepaper: Maintain product integrity in biologic clinical studies
Cold chain shipping challenges & root causes of common reference product sourcing problems.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
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What can we learn from contamination control failures?
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
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Controlling contamination by material transfer
Here, EPR summarises Tim Sandle's review of different methods for transferring items into aseptic areas, including decontamination chambers and pass-through hatches.
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ebook: Guidance on implementation of ARMMs
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
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On-demand webinar: Speed your biologic into phase 1-3 clinical trials
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
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The challenge of handling highly potent API and ADCs in analytical chemistry
Handling highly potent active pharmaceutical ingredients (HPAPIs) or drug product in a laboratory requires implementation of strict security measures. Here, Elodie Barrau and Olivia Jones discuss high potency product handling procedures to ensure continued safety.
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Webinar: Comparator sourcing success
Collaboration between comparator sourcing specialists and clinical supply managers can improve inventory management and supply chain performance.
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Webinar: Responsibilities of specialised clinical supply experts
Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
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Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
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Whitepaper: Bridging the cell and gene therapy gap
The current understanding among sponsors of the workflow from cell collection, to manufacturing, and to the clinical site for patient administration.
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Survey report: Direct-to-patient: industry perception and future trends
Understand the perceived importance of DTP to successful study execution.
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Expert corner: Reframing human error for team success
Watch NSF’s complimentary 30-minute ‘expert corner’ training video on human performance with experts Catherine Kay and Julie Avery.
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New guidance for membrane-based water for injection systems
The new Guide from ISPE presents best practices for design, operation, maintenance and quality of membrane-based water for injection (WFI) systems.
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Article: Addressing the shortage of QPs in the pharma industry
How the pharma industry can tackle the shortage of QPs by Lynne Byers, Senior Director Pharma Consulting, NSF Health Sciences.
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Resources: Single use technologies – the ultimate future
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
