Authors
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Fundamentals of GMP Warehouse DesignStorage and retrieval methods and the unique requirements found in building codes are crucial considerations.
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Industrializing Design, Development, and Manufacturing of Therapeutic ProteinsThe authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.
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Rapid Screening for Elemental Impurities using ICP-MSThe authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.
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Process Analytical Technology Concepts and PrinciplesThis article outlines the key concepts that define process analytical technology and emphasizes the relevant theory and applications of chemometrics.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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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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Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process ConsiderationsUSP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
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Emerging Life Sciences StandardsThis article looks at some of the current and emerging standards that are shaping the life sciences industry, and how pharma and biotech companies can benefit by implementing them.
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Parenteral Drug Association (PDA)PDA is the leading global provider of science, technology, regulatory information, and education for the bio/pharmaceutical community.
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Press Adjustments Help Prevent Tableting ProblemsAdjusting the tablet press and its systems can prevent manufacturing and product quality problems.
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Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process ConsiderationsUSP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
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The Validation and Implementation of a Chromatography Data SystemThis article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.
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Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
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The Development of a Floating Drug-Delivery System for MetronidazoleThe authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
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Application of the Weisberg t-test for OutliersDetermining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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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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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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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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Significant Revisions and Updates to the European PharmacopoeiaRevisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.
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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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ZFN Technology Advances Biopharmaceutical ManufacturingApplications of ZFN technology in biopharmaceutical cell-line engineering.
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Black Specks in Tablet Stability SamplesA study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
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Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical SuppliesStay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
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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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Effect of Extragranular Microcrystalline Cellulose on Compaction, Surface Roughness, and In Vitro Dissolution of a Self-Nanoemulsified Solid Dosage Form of UbiquinonePowdered self-emulsified dosage forms provide an attractive alternative to filled-capsule preparations, but the selection of a proper excipient is crucial.
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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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Foam GranulationThe authors review developments in wet granulation using a twin-screw extruder.
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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.
