INSIGHTS ON QUALITY CONTROL
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![Software Simplifies Compliance With 21 CFR Part 11 And EudraLex Good Manufacturing Practice Volume 4 Annex 11]( "Software Simplifies 21 CFR Part 11 and Annex 11 Compliance")
Software Simplifies 21 CFR Part 11 and Annex 11 Compliance21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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![GettyImages-89952787_cows]( "Challenges In Developing Medical Devices From Animal-Based Biomaterials In China")
Challenges In Developing Medical Devices From Animal-Based Biomaterials In ChinaBovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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![GettyImages-2166459777 digital twins, technology]( "Digitalizing Pharma Control Strategies: A Roadmap")
Digitalizing Pharma Control Strategies: A RoadmapDigitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.
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![alcami nitro web thumb]( "Understanding Nitrosamines: Key Regulations And Best Practices")
Understanding Nitrosamines: Key Regulations And Best PracticesGain expert insights into nitrosamine regulations and discover practical strategies for ensuring compliance and safeguarding product safety.
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How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows2/3/2025
The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.
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Development To Large-Scale cGMP Production7/25/2024
For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.
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Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?4/20/2026
Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.
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Navigating The Analytical Complexity Of Oligonucleotide Therapeutics9/13/2024
From identity and purity testing using chromatography and electrophoresis to PCR and microbial studies, explore advanced analytical solutions tailored for siRNA, miRNA, pDNA, and mRNA products.
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Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy2/6/2026
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
QUALITY CONTROL SOLUTIONS
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![iStock-997784670-selection-chain]( "Supporting Bench To Production Applications For Multiple Industries")
Grow and scale up your manufacturing with the right support, and choose from 92,000+ chemicals provided through an extensive global network of 3,500+ manufacturers.
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![Milliflex Oasis Filtration System for Bioburden Testing]( "Membrane Filtration Method For Productive And Reliable Bioburden Testing")
Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.
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![GettyImages-1746637448-laboratory-tablet-analysis-vial]( "Annex-1 Compliant Robotic Aseptic Powder Fill/Finish Solution")
Precision, automated aseptic powder filling overcomes variability and scale‑up challenges, delivering accurate dosing, regulatory alignment, and a faster, reliable path from development to clinical manufacturing.
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![Performing_Step_2_ELISA_adding_stop_solution_with_color_change]( "The In-Vitro MAT: Compendial Replacement For The Rabbit Pyrogen Test")
Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs testing in the course of pharmaceutical quality control. Test methods being used are the rabbit pyrogen test (RPT), the bacterial endotoxin test (or LAL test), and the monocyte activation test (MAT).
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![Milliporesigma_DSC5087_Burkhold Kopie]( "Microbial Culture Media For Quality Control Of Non-Sterile Products")
Using the correct media is critical to ensure microbiological quality. Explore a portfolio of culture media and substances for sample preparation, microbial enumeration tests, and tests for specified microorganisms.
