INSIGHTS ON REGULATORY COMPLIANCE
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![BIO-EXPO Live]( "From Compliance To Process Control: Enabling Preventive Monitoring Through Smart CPV")
From Compliance To Process Control: Enabling Preventive Monitoring Through Smart CPVLearn to leverage Continued Process Verification (CPV) and analytics for early detection of process drift, enabling preventive monitoring and enhancing overall process robustness.
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![stevanato gmp]( "How RTU Solutions Can Meet GMP Annex 1 Requirements")
How RTU Solutions Can Meet GMP Annex 1 RequirementsEU GMP Annex 1 urges better contamination control. RTU containers help pharma firms reduce risks, cut costs, and streamline aseptic manufacturing with simplified, compliant solutions.
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![Thermo Roundtable screenshot]( "Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials")
Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw MaterialsImprove your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.
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![GettyImages-1287845246-laboratory-bottles-mask-scientist-gloves-coat]( "Advances In Regulations For Viable Environmental Monitoring")
Advances In Regulations For Viable Environmental MonitoringViable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
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Development Of Improved Chromatographic Methods7/31/2025
Explore the evolving role of GLP-1 agonists in weight management and diabetes care, and discover the urgent need for advanced chromatography methods to ensure pharmaceutical quality and safety.
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5 Signs You've Outgrown Your Quality Management System (QMS)12/27/2024
An outdated QMS limits growth. Explore how upgrading to an advanced, configurable system like MasterControl can ensure scalability, automation and innovation.
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Boost Compliance And Efficiency With Real-Time Asset Management9/2/2025
Explore a platform that empowers GMP-regulated industries with a unified EAM, CMMS, and APM platform to boost compliance, efficiency, and asset performance through real-time integration.
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How Digital Innovation Can Inform RWE-Led Decision-Making1/17/2025
Real-world evidence (RWE) is changing how healthcare products are developed and marketed. Learn how digital innovations are helping companies leverage RWE to make better decisions.
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Implementing Rapid Microbial Identification In Biotherapy Manufacutring5/27/2025
Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.
REGULATORY COMPLIANCE SOLUTIONS
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![West]( "What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?")
As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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![503B drug compounding]( "Cleanrooms And Equipment For 503B Outsourcing Facilities")
Germfree understands the unique challenges associated with 503B sterile drug compounding
Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.
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![GettyImages-1214763114 Medical Research Scientist Working In Laboratory]( "Culture Media For Biological Indicators")
Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.
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![SCIEX 5500+ System]( "Quantitative Analysis With The SCIEX Triple Quad™ 5500+ System")
The SCIEX Triple Quad™ 5500+ system is engineered to deliver best-in-class quantitative analysis.
The best just got better. The SCIEX Triple Quad™ 5500+ system is equipped to conquer your laboratory’s most complex workflows and opportunities. With this LC-MS/MS system, you have the sensitivity and performance to meet analytical and regulatory demands for low-level trace detection with ease.
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![Solutions For Injectables]( "Solutions For Injectables And Parenteral Formulations")
Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.
