Authors
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Controlled Release from Porous PlatformsThe authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.
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Why Training MattersInvesting in worker training is crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.
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Why Training MattersInvesting in worker training is crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.
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Understanding Fluidized-Bed GranulationThis study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
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Best Practices for Color CodingPharmaceutical manufacturing facilities can help prevent contamination and cross contamination by using color coding.
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Emerging Markets—An Opportunity for Pharma to Drive Sustainable GrowthCambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.
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Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
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Reducing the Documentation Burden in Process ValidationThe author discusses the collection and evaluation of data part of FDA’s definition of process validation.
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Targeting Nitrosamine Precursors with Novel Active Material Science Scavenger TechnologiesWebinar Date/Time: Thu, Jun 27, 2024 11:00 AM EDT
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EMA Guideline on Setting Health-Based Exposure LimitsThe results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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EMA Guideline on Setting Health-Based Exposure LimitsThe results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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EMA Guideline on Setting Health-Based Exposure LimitsThe results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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EMA Guideline on Setting Health-Based Exposure LimitsThe results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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Cleaning Limits—Why the 10-ppm Criterion should be AbandonedThe 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
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Cleaning Limits—Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part IIConventional limit-setting techniques are not health-based and can make risk assessment more difficult.
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Process Validation: Do We Need Brainwashing?Six years after the guidance, it’s time to change our quality assurance vocabulary.
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Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
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Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
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EMA Guideline on Setting Health-Based Exposure LimitsThe results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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EMA Guideline on Setting Health-Based Exposure LimitsThe results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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What Does the Future Hold for the Animal Rule? Examining FDAs Final GuidanceThe author reviews FDA's final Animal Rule guidance.
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Calculating And Understanding Particulate Contamination RiskThe author presents a method to calculate the relationship between supply air volume flow and airborne particle concentrations.
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Error Assessment of Drug Concentration in Multicomponent Pharmaceutical MixturesA novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities. The method was further applied to calculate the ingredients’ least allowable quantities. This approach ensures that the pharmaceutical formulation is prepared within a given maximum permissible error in drug dose.
