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Killer Asset: Plant Information ManagementIf an inspection reveals any shortcomings ... a manufacturer may be warned, fined, or its facility closed down until full control can be demonstrated to the satisfaction of the authorities ....
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Estimation of Distribution Coefficients from the Partition Coefficient and pKaFor a monovalent species, a simple calculation that does not assume partitioning of the ionized species in the oil phase can provide an accurate estimate of the distribution coefficient.
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ISO Standard for Primary Packaging MaterialsBased on a German initiative, an international standard on quality management systems for the primary packaging materials of medicinal products is discussed in this article. This new directive will help to standardize the production of primary packaging materials by defining global requirements.
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Milling Made Easy: Nanoindentation as a Predictor of Bulk PropertiesSize reduction of materials through comminution is employed in many industries, including agrochemicals, minerals, ceramics and pharmaceuticals. The reasons for particle size reduction depend on the industry in question. Within the pharmaceutical industry, a large percentage of products are formed from powders and undergo processing to improve dosage form properties. Particle size reduction prior to compacting to tablets can aid with dissolution and homogeneity. Such processing of powders is, in part, dependent on their mechanical properties and balancing these properties is crucial in achieving desired manufacturing performance. Generally, pilot-scale milling trials are run to determine the most effective and efficient mill and operating conditions for each material. These trials, however, require relatively large quantities of material as well as time, and are normally run in early development when sufficient material becomes available. Hence, it would be highly beneficial to identify a physical property..
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FDA’s Guidance on Quality Metrics: Possible Implications for Contract Testing Laboratories*This article is an opinion piece and does not necessarily represent the views of BioPharm International.
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Coding and marking technologies for the pharmaceutical industryThe right choice [of coding and marking technology] depends upon the company's top priorities regarding legibility, cost, speed, ease of use, cleanliness and security.
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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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One-Pot Processing And The Benefits For GranulationOne-pot processing is a term that includes any technology that combines different unit operations of a pharmaceutical production process into one machine.
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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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Maximizing Sample Information with High Sensitivity MSn and Fast Cycle Time on a Linear Ion Trap Mass SpectrometerRapid structural elucidation of compounds in complex mixtures is a powerful technique in metabolite, degradation and process control applications. The ability to follow the fragmentation pathway through sequential MSn transitions provides added confirmation and increases the selectivity for monitoring compounds of interest in a complex mixture. Previously, the limiting factors in applying this technique were sensitivity at MS4 and higher transitions, and the cycle time required to acquire multiple MSn spectra across a narrow LC peak. Recent developments in trapping, detection efficiencies and scan rates have reduced these limitations and enabled rapid characterization of multiple compounds from single chromatographic runs.
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Automated Compliance: Reducing Costs and Maintaining QualityIn an interview earlier this year (Bio-IT World, April 2003), Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), stated that "The original intent of the rule (21 CFR Part 11) was to facilitate the introduction of electronic technology to the process of the US Food and Drug Administration (FDA) submissions, as well as manufacturing and production. Part 11 was created to provide common-sense guidelines on how to do in the electronic world what was previously done on paper. During the last 5 years, however, confusion regarding what is included in the regulation and how to enforce it was impeding the introduction of new technology. The rule had created exactly the opposite of what was intended."
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Maintenance Qualification: Improving Compliance and Performance in Pharmaceutical ManufacturingThis article describes the approach to maintenance management that delivers enhanced compliance for direct impact GMP systems...
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The influence of concomitant use of alcoholic beverages on hypromellose matrix tabletsResearch shows that both drug prescription and alcohol consumption increase within the elderly population. It is, therefore, necessary to fully understand the impact of alcohol consumption on solid oral dosage forms, especially extended release formulations.
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Changes in US Policy: What Generic Pharmaceutical Companies Need to KnowIn this article the authors examine a number of significant amendments to US policy regarding generic pharmaceuticals. These important changes could have a major impact not only on the US pharmaceutical market, but also globally. The US Food and Drug Administration (FDA) implemented new regulations, effective from 19 August 2003, that promise to benefit generic pharmaceutical companies in several ways. Significantly, they seek to prevent multiple 30-month stays and resolve much of the uncertainty regarding which patents may properly be listed in FDA's Orange Book.1,2
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HPLC Method Development and Validation for Pharmaceutical AnalysisThis article presents a simple and systematic approach to HPLC method development, beginning with sample preparation and finishing with practical analytical method validation.
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Positron Emission Particle Tracking Studies of a Wurster Process for Coating ApplicationsWurster coating provides excellent film uniformity and god active-component distribution. The authors describe the results of a study using the Wurster method with positron emission particle tracking technology.
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Improving Protein Capture for Transgenic Drug ProcessingOne of the greatest challenges facing biopharmaceutical manufacturers has been the primary recovery of recombinant materials from transgenic sources. As an alternative to existing methods, vibrating membrane technology, which is widely used in food and beverage processing, recently has been adapted to biopharmaceutical applications involving transgenic biosolutions.
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Taming the Regulatory Beast: Regulation versus FunctionalismMass spectrometrists working in pharmaceutical development tend to approach the issue of regulatory compliance with some trepidation...
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Cleanroom Pressurization MethodologyFacilities with rigidly controlled environmental parameters can take steps to meet precise and repeatable conditions.
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Defining and Managing Raw Manufacturing DataProtecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
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Keeping Supply Chains HealthyToday's fast-paced global market place has created a critical need for efficient international supply systems in the healthcare sector...
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Organic Impurities in Chemical Drug SubstancesChemical purity is the most important quality characteristic of a pharmaceutical substance. This article describes the latest scientific and technological advances to meet recent pharmacopoeial and regulatory requirements regarding the control of organic impurities in synthetically produced active substances. Future developments and suggestions for those working in quality control and raw material selection are discussed.
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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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Nanotechnology Applications for Drug DeliveryNanotechnology is believed to hold enormous promise for the future of medicine and healthcare...
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The Hidden Economic of Calibration ManagementThe importance of calibrating instruments used in manufacturing processes is well known, particularly for highly regulated industries such as pharmaceutical production. This article discusses software applications used to support calibration management, and the potential economic gain to be had by replacing a standalone software application with a capable enterprise system.
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The Need for Effective Document Change Management in the Pharmaceutical IndustryWith the advent of regulations such as 21 CFR Part 11 and the introduction of the electronic common technical document, it is becoming increasingly important to be able to enhance and fully utilize data management systems. Document change management is a vital tool in the construction and organization of valuable information, and can play a key role in the all-important process of getting a product to market.
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Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive PowdersIn this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
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New Developments in Spray-Dried LactoseRecent advances in spray-drying technology have led to the production of new directly compressible lactose grades with distinct advantages.
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Residual Solvent Analysis in PharmaceuticalsResidual solvents in pharmaceuticals are organic, volatile chemicals that are either used or produced during the manufacture of actives, excipients or drug products. These chemicals may be hazardous to human health; however, their acceptance limits and classification vary among the three major pharmacopoeia. In this article, the author discusses the regulatory status of the various classifications of residual solvents with regard to the European, US and Japanese pharmacopoeia.
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Protecting Intellectual Property Prior to CommercializationThis article looks at the different approaches to patenting in Europe and the US...
