Authors
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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The Relevance and Readiness of AI for GMP Manufacturing: An Industry PerspectiveLeverage artificial intelligence (AI) for a more streamlined GMP manufacturing process.
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Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory ContextLife sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.
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EGA Position On The EC's Proposal For A Falisifed Medicines DirectiveAlthough the European Generic medicines Association (EGA) n has welcomed the European Commission's proposal for a Directive on the falsification of medicines, it has also identified subjects that are of specific relevance to the European generic medicines industry.
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Optimizing bio-decontamination in asseptic productionIt analizes how to optimize a bio-decontamination process using an atomized hydrogen peroxide new cycle development method for use in pharmaceutical aseptic enclosures.
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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Improving Packaging SecurityLegislation has prompted the pharma industry to seek technologies that can be used to secure a product throughout the supply chain.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Pooling of Batches for Stability Data AnalysisOne of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability.
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Viewpoint: Data Integrity and Its Ties with Personal IntegrityThe root cause of the most serious integrity issues has generally been a lapse of ethical behavior on the part of an individual.
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Actylis Biopharma CapabilitiesWe demonstrate the wide range of customized products and services that Actylis offers its biopharma customers.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Industrial Applications of Whole-Cell BiocatalysisRecombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.
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Verifying Compendial MethodsExperts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.
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The Buyer’s Guide to Pharmaceutical QMS v2For a pharmaceutical manufacturer, choosing the QMS that is right for you can be a daunting task. This guide offers a review of the obstacles most likely to hinder a quick, smooth, and effective QMS implementation.
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Effect of Binder Type and Binder Level on the Properties of Agglomerates Containing Lactose and Dibasic Calcium Phosphate DihydrateThe authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate.
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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Navigating the Complexities of Drug FormulationFor the pharmaceutical industry, drug formulation is a cornerstone, crucial for converting bioactive molecules into effective, stable, and patient-friendly medications.
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From Concept to Culture: Elevating GMP Compliance in Life SciencesWebinar Date/Time: Thu, Mar 14, 2024 2:00 PM EDT
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The Era of Digital Data in Bio/Pharma ManufacturingLaks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Navigating the Formality Spectrum in ICH Q9(R1)The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.
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Assessment of Nanosuspension Formulation for Intranasal AdministrationResearch suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
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Contamination Prevention: How Single-Use Systems Can Ensure a Safe, Clean, and Efficient Bioprocess EnvironmentThe authors focus on how single-use systems effectively control three potential sources of common contamination: cross contamination, microbial contamination and biologic contamination of the process facility.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
