Authors
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What Will It Mean to the Patient?Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.
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Roller Compaction Feasibility for New Drug Candidates: Laboratory to Production ScaleThe authors provide a method to predict whether a material is suitable for dry granulation by roller compaction.
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Asset Management Tools for Minimizing Regulatory Risk and Maximizing EfficiencyResolving the asset headache - the author explains how effective asset management can enable pharmaceutical companies to boost operational profit, increase production uptime and adhere to regulatory standards.
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Near-Infrared Spectroscopy as a Process Analytical ToolImproving product quality and lowering costs are the key factors behind the decisions made in many industries. Ensuring product quality throughout the manufacturing process can be time-consuming, with materials and products 'quarantined' until test results are generated. Rapid testing by near-infrared (NIR) spectroscopy at all stages of the manufacturing process can reduce production time and provide assurances at each step of the process that product quality is being maintained.
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The influence of monoglycerides, mixtures and derivatives on the formation of pellets by extrusion/spheronizationThe previous studies on the incorporation of glyceryl monostearate into pellets by extrusion/spheronization has been extended to include a range of grades of this material plus a mixed medium chain partial glyceride and two glycerol esters of hydrogenated natural glycerides as described in this article.
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Configuring Software for Compliance with 21 CFR Part 11 Audit Trail RequirementsUntil specific audit trail requirements are available from the US Food and Drug Administration, manufacturers must define their own parameters for software system compliance and decide for themselves how to meet those requirements.
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Parallel trade still a grey area for GSKThe refusal to sell was motivated by a desire to maximize GSK's profits, and GSK had not shown that not having these profits would prejudice consumers by restricting GSK's R&D.
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Microstructured transdermal systems for intradermal vaccine and drug deliveryThe needle and syringe have long been the standard delivery technology for vaccines. However, a confluence of market factors is driving new interest in alternative delivery systems that hold the potential to meet one or more of the following goals: improved antigen utilization, higher quality immune response, better stability and improved patient acceptance. Of particular interest are microneedle systems, otherwise referred to as microstuctured transdermal systems (MTS), that provide for targeted delivery of the vaccine formulation directly to antigen-presenting cells within the epidermis. This article provides a brief overview of MTS technology with an emphasis on solid-coated MTS for vaccine delivery.
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Dropping Method Solution for Formulating Solid DispersionsThe use of solid dispersion technology to increase the bioavailability of poorly water-soluble drugs has always been limited by processing and scale-up difficulties. A new approach may help to overcome some of the problems.
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Coming to Terms with ComplianceThe pressure on the pharmaceutical industry to manufacture products faster and more cost-effectively has never been greater. Additionally, companies must also meet stringent regulations set by authorities such as the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). This article explores the importance of complying with regulations and validation, how to maintain compliance and looks at some of the consequences of non-compliance.
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Synthetic Excipients Challenge All-Natural OrganicsSynthetic excipients frequently offer advantages over all-natural compounds.
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Improving Dose Content Uniformity Testing for MDIs and DPIsIt has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.
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From the Formulator to the Tablet Manufacturing Floor: Desiderata and TroubleshootingTablet manufacturers often overlook critical basic concepts or established practices. The author draws from his own experiences and discusses how solid dosage manufacturers can improve production and product quality by optimizing major unit operations.
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Particle Engineering for Improved Dispersion in Dry Powder InhalersRespirable drug delivery is becoming increasingly popular because it provides a non-invasive route with rapid drug uptake, not only for the treatment of respiratory complaints, but also for the systemic delivery of substances that cannot be delivered orally.
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The Granulation Process 101: Basic Technologies for Tablet MakingThe author offers a primer for choosing the correct granulation process to improve yields, reduce tablet defects, and enhance productivity.
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Analytical Techniques for Oral Solid Dosage FormulationAnalytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.
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Aqueous Cleaning and Solvent Substitution in Chemical Synthesis API ManufacturingOrganic solvents are frequently used in the manufacture of active pharmaceutical ingredients. They have, therefore, normally also been used for process cleaning. However, a number of factors have encouraged the industry to change from solvent-based to aqueous cleaning. This article considers current cleaning practices, related issues and the author's experience of switching from one cleaning method to another.
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Certificates of Test - What are the European GMP Requirements?This article examines European differences in GMP requirements for the acceptance of Certificates of Tests. The authors look at how pharmaceutical manufacturers can address the issues and suggest a US-compatible framework for GMPs that could be incorporated into EU requirements.
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Characterization of Polymeric ExcipientsThis article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.
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Integrated Compliance ManagementManufacturing exceptions and variability often can be managed more effectively through integrated, enterprise-wide systems.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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The Application of Cryogenics for Sustainable Solvent RecoveryEmissions control has long been a primary concern for the pharmaceutical processing industry in Europe, which relies on the use of a number of organic solvents for the manufacture of pharmaceutical products...
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Why Search Matters: Information Retrieval in the Pharmaceutical IndustryInformation retrieval (IR) deals the representation, storage, organization of unstructured applying natural-language processing,semantic relationships, linguistic analyses,behavioral histories, and “fuzzy” statistical techniques to help human quickly find and retrieve the information they seek.
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The Relationship between Saturated Hydrogen Peroxide, Water Vapour and TemperatureHydrogen peroxide has become the compound of choice for gaseous biodecontamination in the pharmaceutical industry. As some processes operate at vapour concentrations below the dew point, to avoid condensation, and others actually form dew, it is important to understand the relationship between the vapours and to have a method of establishing the dew point.
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Experimental and computational methods for understanding pharmaceutical flows, Part II: Large-scale production equipmentFlow problems, such as process performance and reliability, can be improved using a combination of experimental and computational methods.
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A Risk-Management Approach to Cleaning-Assay ValidationThe authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.
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PhRMA Perspectives on Drug Substance Regulatory Filing IssuesThe PhRMA API Technical Group examines topics concerning active pharmaceutical ingredient development and manufacture and makes recommendations for regulatory guidance.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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The Benefits of Process Information Management in R&D - A Case StudyThis case study examines the benefits of introducing process information management software to a pharmaceutical pilot plant. The advantages illustrate the potential for process development and commercial manufacturing improvements that are available to the pharmaceutical industry.
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A Novel Compression-Coated Tablet Dosage FormThe authors modified a three-layer press to operate a compression-coated tablet process that may offer several advantages over tradditional compression coating operations.
