Authors
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Single-Use Technology in Parenteral Fill/FinishApplication of single-use technology in a parenteral facility for syringe filling.
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ZFN Technology Advances Biopharmaceutical ManufacturingApplications of ZFN technology in biopharmaceutical cell-line engineering.
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Black Specks in Tablet Stability SamplesA study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
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Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical SuppliesStay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Effect of Extragranular Microcrystalline Cellulose on Compaction, Surface Roughness, and In Vitro Dissolution of a Self-Nanoemulsified Solid Dosage Form of UbiquinonePowdered self-emulsified dosage forms provide an attractive alternative to filled-capsule preparations, but the selection of a proper excipient is crucial.
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Single-Use Technology in Parenteral Fill/FinishApplication of single-use technology in a parenteral facility for syringe filling.
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Foam GranulationThe authors review developments in wet granulation using a twin-screw extruder.
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Certificates of Test - What are the European GMP Requirements?This article examines European differences in GMP requirements for the acceptance of Certificates of Tests. The authors look at how pharmaceutical manufacturers can address the issues and suggest a US-compatible framework for GMPs that could be incorporated into EU requirements.
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Single-Use Redundant FiltrationThe authors describe a new assembly for bulk and final drug product filling operations.
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Freeze-Drying Process Optimisation for a Small MoleculeFor true freeze-drying cycle optimisation, information on the maximum allowable product temperature during primary drying is required.
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Single-Use Technology in Parenteral Fill/FinishApplication of single-use technology in a parenteral facility for syringe filling.
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Single-Use Technology in Parenteral Fill/FinishApplication of single-use technology in a parenteral facility for syringe filling.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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A New Approach to Forced Degradation Studies Using Anhydrous ConditionsIn this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.
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Fixed-Dose CombinationsFixed-dose combinations (FDCs) reduce the number of pills that must be taken, but they have also been a topic of concern, mainly because of the perceived potential for increased adverse events. PTE speaks with researchers to explore the benefits and concerns of FDCs.
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Understanding Containment for TabletingRisk levels should be considered when designing containment for pharmaceutical tableting equipment to enhance operator safety.
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Applications in Pharmaceutical ManufacturingThe use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and OpportunitiesAssessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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Documentary EvidenceA look at the role of document management in the product life-cycle and how this can lead to the effective use of CTDs and e-CTDs when compiling compulsory regulatory submissions...
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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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Deficiencies Found in API InspectionsPIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
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Multilayer Tablets: A Piece Of Cake?Multilayer tablets: A piece of cake or just a passing fad? We bring experts together to find out.
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Using Analytical Techniques to Examine Tablet StickingAnalytical tests, correlated with statistical techniques, are used to predict material behavior.
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Early Development GMPs for Stability (Part IV)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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Deficiencies Found in API InspectionsPIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Early Development GMPs for Stability (Part IV)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
