INSIGHTS ON QUALITY CONTROL
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The Future Of QC: Robotics And Automation
See how pharma 4.0 is revolutionizing the pharmaceutical industry with automation and digitalization to transform microbiological quality control labs into efficient, real-time-monitored environments that enhance productivity.
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Advancing Cell Therapy Manufacturing: Rapid Sterility Testing
The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.
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The Pain Of Change – Could Suppliers Be Part Of The Cure?
Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.
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Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation
Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.
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ICH Q9 Revision 1: Enhancing Quality Risk Management8/12/2024
ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
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Optimizing Contamination Control: Strategy Planning And Execution7/25/2025
A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.
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Aseptic Expertise And Delivery Of Services8/20/2024
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
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Method Migration Of A Normal Phase HPLC Method For Tocopherols9/17/2024
The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.
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Manufacturing Solutions3/4/2025
Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.
QUALITY CONTROL SOLUTIONS
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Lateral Flow API Weighing and Dispensing Enclosure designed to provide personnel and product protection when weighing 0.5 kilograms (kg) of API powder.
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Flow Sciences, a leading provider of containment solutions for laboratory, pilot plant, and manufacturing facilities consults with third party industrial hygienists to conduct in-house Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure customers’ products perform at the level they need.
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In pharmaceutical testing, the development and validation of analytical methods are absolute musts when it comes to reliable quality control. Natoli Scientific is at the forefront of offering comprehensive analytical method development and validation services designed to ensure the integrity of your company’s drug formulations. Our expert team develops robust methods tailored for each unique compound, with an approach that emphasizes precision, accuracy, sustainability, and compliance with regulatory standards such as the FDA and ICH guidelines. These methods are meticulously validated to confirm their reliability across a range of analytical parameters including specificity, sensitivity, linearity, and reproducibility.
This validation process is critical for verifying that our methods produce consistent, trustworthy results throughout the product’s lifecycle, thus fostering confidence in the safety and efficacy of pharmaceutical products.
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Our highly skilled team of chemists and process engineers, combined with a science-driven project management approach, ensures seamless execution at every stage.
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Ensure your equipment meets stringent regulatory expectations with an instrument qualification service that supports you through installation, maintenance, and modifications for compliance.