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The Impact of Vortexing on the Particle-Size Distribution of PharmaceuticalsIf a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size distribution.
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Managing Hazardous Waste from Pharma ProcessesPharmaceutical manufacturers must stay compliant with changing regulations for hazardous waste disposal.
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Best Practices in Analytical Method Development and TestingThis article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
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Microbiology & toxicology testing services for the medical device and pharmaceutical industries.Wickham Laboratories Ltd is a trusted name in the pharmaceutical and medical device industries with over 50 years of experience in contract testing, research and consultancy.
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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.
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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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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.
