Authors
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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.
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Achieving Zero-Order Release Kinetics Using Multi-Step Diffusion-Based Drug DeliveryZero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.
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Why EU Pharmaceutical Companies are Being Forced to RelocateDuring the last few years, it has become increasingly apparent that many large pharmaceutical companies are moving their research and development operations to the US, leaving Europe with increasing numbers of smaller companies. This article briefly examines the possible motives for relocation, including the impact of regulation differences between the US and Europe.
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Predicting Meaningful Process PerformanceProcess design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
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Development of PVA Copolymer CapsulesThe bioavailability of some insoluble drugs is enhanced when they are dissolved in the solubilizing agent macrogol 400, although conventional hard capsules cannot tolerate the agent. This article investigates a PVA copolymer, which has been developed by the authors, examining its properties and its suitability as a material in capsule formulations.
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Preclinical Dose-Formulation StabilityWhen designing stability protocols, formulation, storage, and dosing conditions must be assessed.
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Understanding Excipient Characteristics to Ensure Robust Continuous ManufacturingKey information is needed for excipients and their potential impact on continuous manufacturing processes.
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Carbon Measurement Methods for Cleaning Validation: Comparing Direct Combustion with Rinse and Swab Sampling Methods.Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.
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21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current RuleFDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.
