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Developing and Sustaining a Quality CultureEmployee training-at all levels-is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.
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Investigation of Various Impurities in FebuxostatFebuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
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A Practical Approach of Implementing GMP for ExcipientsUsing a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
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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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Assessing and Improving the Palatability of PharmaceuticalsTaste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.
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One Step Back, Two Steps Forward to Improved Quality ProcessesLife-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.
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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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Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process ConsiderationsUSP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
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Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process ConsiderationsUSP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Manufacture and Dissolution Studies of Lipid Spheres: Part IIPrevious articles have presented a general review of the different types of spheres that can be obtained using a rotary fluidized bed process.1,2 Part I of this study focussed on lipid spheres prepared using hydrogenated castor oil for formulations with low active drug content. The feasibility of the process and the main characteristics of spheres obtained were also studied. In Part II, formulations with higher concentrations of active drug are examined.
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Preclinical Dose-Formulation StabilityWhen designing stability protocols, formulation, storage, and dosing conditions must be assessed.
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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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Multifactor Non-linear Modeling for Accelerated Stability Analysis and PredictionThe right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.
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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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New Research Revealed on a Promising Functional Alternative to Surfactants within Biologic FormulationsNew research shows KLEPTOSE® BIOPHARMA as a potential functional alternative to surfactants within biologic formulations, learn more from Roquette’s experts Peter Ferguson and Pen Tao. Live: Tuesday, Oct. 29, 2019 at 9am CDT | 10am EDT | 2pm GMT | 3pm CET On demand available after airing until Oct. 29, 2020 Register free
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Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
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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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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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Breaking The MouldPTE interviews Accu-Break's David Beach about using multilayer technology to create accurate breakable tablets and flexible fixed-dose combination drugs.
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Cellular and Gene Therapies Face a Manufacturing Capacity CrunchCellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.
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Trouble-Free LyophilizationEfficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.
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Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
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Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process ConsiderationsUSP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
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Application of the Weisberg t-test for OutliersDetermining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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Establishing Global GMP Compliance with an Enterprise Calibration Management SystemCalibration management systems can lead to cost-effective global compliance when coupled with advances in information technology.
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Monitoring Airborne Micro-organisms in Blow-Fill-Seal TechnologyThe article describes the basic principles of blow-fill-seal (BFS) technology together with the advantages it offers. Although BFS technology is an ideal process for aseptic filling of liquid pharmaceutical products there is still a risk of contaminating the product inside the filling area. This, together with regulatory requirements for the microbiological control of critical areas in pharmaceutical production, makes microbiological monitoring a necessity.
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Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
