INSIGHTS ON QUALITY CONTROL
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![afton aug 1]( "Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety")
Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product SafetySterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.
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![GettyImages-1135102018 tablet]( "The Role Of Quality By Design In Pharmaceutical Tablet Development")
The Role Of Quality By Design In Pharmaceutical Tablet DevelopmentQuality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.
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![Strategic CMC Planning]( "Strategic CMC Planning Through A Phase-Appropriate Quality Approach")
Strategic CMC Planning Through A Phase-Appropriate Quality ApproachA phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.
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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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EMPQ And Validation Support Services2/21/2024
A 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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Pharma Custom Isolator For Sterile Lab Process6/19/2024
This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.
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Implementing A Risk-Based Approach To Calibration2/20/2024
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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Characterizing The Physical Properties Of Spray Dried Powders10/21/2024
Ensure the success of your spray-dried powder formulations by thoroughly assessing their physical properties early in the development process to optimize handling, stability, and performance in final dosage forms.
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Your Guide To Precise And Robust Separation Methods11/12/2025
Discover a detailed guide to characterizing GLP-1 receptor agonists that covers advanced LC-MS and SEC-MALS workflows for impurity profiling, stability testing, and aggregate analysis.
QUALITY CONTROL SOLUTIONS
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![GettyImages-1441662840-lab-team-communication-collaboration]( "Secure Your Pharma Analysis & QC")
Explore an extensive analytical chemistry and microbial testing compliant portfolio for pharmaceutical analysis and quality control (QC) from early-stage drug development to product release.
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![Affinity-ITC]( "Microcalorimeters For In-Depth Characterization")
Powerful tools for characterizing protein-protein interactions, structural stability, and formulation compatibility.
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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.
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![Flow Sciences.jpg]( "Performance Validation by Third Party Industrial Hygienists")
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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![Lighthouse]( "Container Closure Integrity Testing Using Gas Ingress")
The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.
