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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.
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Studying In Vitro Skin Preparation and Drug Release to Optimize Dermatological FormulationsIn vitro skin penetration and drug-release studies are the simplest and most cost-effective methods for characterizing a drug's skin absorption and penetration profiles.
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The Usefulness of 0.45 µm–Rated Filter MembranesIn this study, the authors examine the suitability of 0.45 µm–rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.
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A Novel Amorphous Delivery System to the Skin for Poorly Soluble ActivesDrugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.
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Optimizing Cross-Organizational Team Performance and ManagementTreating a cross-organizational team as a full-fledged partnership helps complete a project on time and on budget.
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Excipient Quality EssentialsDefining quality for excipients may not be as clear cut as it is for APIs, but it is essential to product quality and patient safety, and to choosing the best supplier.
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A reliable method for producing highly purified water.This article describes the quality of highly purified water and its applications, addressing why ultrafiltration (UF) is being used as a downstream purification process. It aims to show that UV is a real alternative for producing pyrogen-free water. This method allows essential cost savings compared with distillation and guarantees a higher safety than other membrane methods such as reverse osmosis.
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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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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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Regulatory Update: The IPEC Novel Excipient Safety Evaluation ProcedureThe authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
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Automated artwork generationThis article examines automated artwork generation, which enables pharma companies to generate validated artwork for their products' packaging. Automated artwork generation is based on a complete set of data stored in an artwork management system. It enables the dynamic assembly of artwork documents, accelerates traditional processes and significantly reduces costs.
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Comparing Different Granulation TechniquesGranulation is one of the most important unit operations in the production of pharmaceutical oral dosage forms. However, there are many different technologies each having different strengths and weaknesses. Most companies choose which one to use simply based on their own experience. This article introduces different processes, compares them objectively and offers unbiased advice on the merits of each system. It then looks at the implications of selection on two different applications.
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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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Rapid progress in pharma RFIDDrug companies have come to realize that spending heavily on creating new blockbuster drugs is risky and less cost-effective ...
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Credit crunch bites R&DA possible recession in the US and a global credit crunch are going to be major factors in the amount of money available as shareholders tighten their purse-strings.
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Applying Good Laboratory Practice RegulationsGood laboratory practice (GLP) regulations became effective in 1979 under 21 CFR Part 58 and apply to all non-clinical safety studies intended to support research permits or marketing authorizations. This article introduces some key elements regarding the application of GLP regulations as a quality system and how GLPs are perceived internationally.
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A Stability Program for the Distribution of Drug ProductsThe authors outline stability studies designed to evaluate the effect of temperature excursions on product quality that may occur during distribution.
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Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical ManufacturingThis article discusses the use of ion mobility spectrometry as an alternative to high-performance liquid chromatography to reduce the amount of time spent on the cleaning verification process.
