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Driving Data Quality and Ensuring Compliance Using Modern CDS SolutionsThe most safe and effective therapies demand the highest data quality.
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Improving Production: How IT, OT, and Quality Can CollaborateTo improve production in pharmaceutical manufacturing, the IT, OT, and Quality functional groups must work together to get the most value from existing plant data.
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Improving Production: How IT, OT, and Quality Can CollaborateTo improve production in pharmaceutical manufacturing, the IT, OT, and Quality functional groups must work together to get the most value from existing plant data.
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Biosimilar Analysis: A Varied ApproachUsing several techniques at different conditions during biosimilar analysis testing offers an improved understanding of a dynamic situation.
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Unprocessed Bulk Testing for BiopharmaceuticalsUnprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.
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Simulating Reality in Mock InspectionsMock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
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Quality's Unsung Hero: The GxP Training MatrixCompanies can benefit from developing a single programmatic approach to a GxP training matrix.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Digitalization of QbD Risk AssessmentsQuality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
Latest:
Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Enhancing the Solubility of Active Pharmaceutical Ingredients Using Hot Melt Extrusion and Polyvinyl Alcohol (June 2023)This whitepaper describes how hot melt extrusion (HME) and a specially-engineered grade of polyvinyl alcohol (Parteck® MXP polyvinyl alcohol 3-82 Emprove® Essential Ph Eur; referred to in this publication as Parteck® MXP 3-82 PVA) can be used to increase the solubility of DCS IIb molecules.
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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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Using Digital Tools to Optimize Facility DesignDigital tools, such as building information modeling (BIM) software, improves efficiency for optimizing pharmaceutical facility design.
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WHEATON® Primary Packaging Solutions manufactured by SciLabwareWHEATON® primary packaging solutions manufactured by SciLabware SciLabware Limited, a company of DWK Life Sciences, is one of the world’s leading manufacturers of high quality primary packaging solutions to the diagnostic and pharmaceutical industries across the globe.
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Continuous Processing: Challenges and Opportunities of Virus FiltrationRequirements for virus filtration must be considered in developing continuous downstream processes.
