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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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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.
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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.
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Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFsAppendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
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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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FT-IR Identification: the Expertise Required To Ensure ComplianceBy providing an information "fingerprint", infrared red spectroscopy is a useful tool for identifying counterfeit pharmaceuticals. The authors identify best practices for ensuring compliance.
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Choosing Containment Strategies For Highly Potent APIsSafe handling of HPAPIs requires determining exposure potential and selecting appropriate containment strategies.
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Contamination: Invisible And AirborneMillions of pounds worth of products are at risk if contamination occurs in a cleanroom environment. According to an independent consultant (Cleanroom Management Associates Inc) for our company, contamination from personnel and equipment, such as wheeled carts and tanks, is a major concern in cleanrooms and controlled environments.
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Best Practice: Testing Softgel CapsulesTexture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.
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Best Practice: Testing Softgel CapsulesTexture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.
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Testing the Integrity of Lyophilized Product ContainersNon-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.
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Updates on Container Closure Integrity Testing for Sterile InjectablesChanges in CCIT testing have followed the evolution of regulatory guidance, and this article examines different possible CCIT strategy approaches.
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Specimen Logistics: The Rx for a Better DxUsing best practices in specimen preparation, packaging, and shipping can improve efficiency for diagnostic laboratories.
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Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in MaltaThe authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
