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Evolving your Micro QC Lab with LIMS integration for Colony CountingWednesday, February 16, 2022 at 9 AM EST | 6 AM PST | 2PM GMT | 3 PM CET & 11AM EST | 8AM PST | 4PM GMT | 5PM CET How are you approaching Pharma 4.0 and the QC Lab of the future with automation? Join us for an informative Webinar on the benefits of end-to-end integration with LIMS and QC Micro automation.
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UV Spectroscopy Gains Use in Dissolution TestingKeith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.
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FDA Perspectives: Understanding Challenges to Quality by DesignDirectors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.
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Scientific Approach Ensures Accurate Weighing ResultsUnderstanding of the basic principles of balance and scale enables a user to achieve a qualified weighing process.
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Statistical Tools to Aid in the Assessment of Critical Process ParametersThere are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
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Statistical Tools to Aid in the Assessment of Critical Process ParametersThere are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
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Statistical Tools to Aid in the Assessment of Critical Process ParametersThere are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
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Statistical Tools to Aid in the Assessment of Critical Process ParametersThere are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
Latest:
Statistical Tools to Aid in the Assessment of Critical Process ParametersThere are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
Latest:
Statistical Tools to Aid in the Assessment of Critical Process ParametersThere are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
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Designing a Biomanufacturing Facility Incorporating Single-Use TechnologiesAsking the right questions is crucial to establishing a biopharmaceutical facility design.
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Designing a Biomanufacturing Facility Incorporating Single-Use TechnologiesAsking the right questions is crucial to establishing a biopharmaceutical facility design.
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Qualification and Validation of Single-Use Shipping SystemsIn this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.
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An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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Qualification and Validation of Single-Use Shipping SystemsIn this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.
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Addressing Dust Accumulation in Tablet ManufacturingDedusting equipment and techniques address problems associated with tablet manufacturing dust accumulation.
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Planning a Biologics Facility Start UpIntegrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
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Forced Degradation Studies for BiopharmaceuticalsThe author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
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Choosing Tableting Tooling for Compressing Abrasive FormulationsWear-resistant materials and coatings protect tablet punches and dies from abrasive formulations.
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Considerations for Tablet Compression with Multi-Tip ToolingThis article examines multi-tip tool technology for pharmaceutical tablet compression and the process control and validation issues that must be carefully evaluated to assess the potential for success.
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Meeting USP Guidelines for Elemental Impurity Analysis with X-ray Fluorescence SpectrometryThe author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.
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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug SubstancesThe authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug SubstancesThe authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
