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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![Field Service Automation]( "EMPQ And Validation Support Services")
EMPQ And Validation Support ServicesA growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.
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![Aseptic Expertise and Delivery of Services]( "Aseptic Expertise And Delivery Of Services")
Aseptic Expertise And Delivery Of ServicesA 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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![05 West]( "Leachables Method Development, Validation And Relevant ICH References")
Leachables Method Development, Validation And Relevant ICH ReferencesIt is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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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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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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The Scalability Of Depth Filters For CHO Cell Culture Clarification7/19/2024
Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.
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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.
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Integration Of Container Closure Integrity In Contract Manufacturing3/28/2025
Maintaining drug product sterility and compliance demands rigorous Container Closure Integrity (CCI) within contract manufacturing. Learn how to fortify your processes.
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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![HPAPI Package Inspection Enclosure]( "HPAPI Package Inspection Enclosure")
The HPAPI Package Inspection Suite is designed to provide personnel and product protection down to a respiratory exposure of at least 100 micrograms per cubic meter air (100 ug/m3). Package inspection operations involve manipulation of highly potent pharmaceutical ingredients (HPAPI), such as fentanyl.
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![Lighthouse Headspace Analyzer]( "Pharmaceutical Water Activity Analyzer: FMS")
LIGHTHOUSE’s FMS-Water Activity Analyzer measures the water activity (% RH) of drug product samples.
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![Biotech scientist looking at test tube]( "Chemical Products And Services At A Glance")
Explore end-to-end solutions and products suited to your organization, whether for research and discovery or planning for scale to commercial manufacturing.
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![Syringe-Staked-In-Needle-iStock-502347386 (002)]( "Pharmaceutical Package Integrity Testing")
The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
