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Industry 1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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Compliance vs. Competency: Designing CGMP Training with Performance Outcomes in MindAlternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.
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Manufacturer Guidelines for the Secure Destruction of Controlled Substance PharmaceuticalsPharma manufacturers must securely destroy expired or off-spec drugs to meet DEA standards, avoid compliance risks, and protect public safety.
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Optimizing Drug Delivery Methods With NanotechnologiesShaukat Ali, PhD, Senior Director of Scientific Affairs and Technical Marketing, Ascendia Pharmaceuticals, highlights the benefits of the company’s nanotechnologies in supporting formulation development of poorly soluble molecules.
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Steps Towards Demystifying Risk-Based Decision MakingIt is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Active Packaging Reimagined: Novel Technologies to Derisk Drug Product StabilityStability and moisture challenges are likely to increase with the development of more potent APIs, larger molecules, and modified-release tablets. Learn about innovative packaging solutions to address the increasing need to protect hydrophilic oral solid doses from moisture and preserve drug stability. Live: Thursday, Sept. 17, 2020 at 11am EDT| 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 17, 2021
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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A Risk-Based Approach to Monitoring Elemental Impurities in Leachable StudiesThe authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.
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Effective and Efficient Weighing of Potent CompoundsThe advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
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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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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing BottleneckGlobal scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.
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Executive Summary: Leveraging the Evolving Bioequivalence Regulatory Landscape to Enhance Inhaled Product Design and DevelopmentThe regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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5 Strategic Success Factors for Secondary Packaging and Device AssemblyStarting early to discuss the secondary packaging strategy can save you time and money. From our experience as a globally leading CDMO we would like give you some food for thought.
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Delivering on the Potential of mRNA TherapeuticsThe complexity of the RNA production process creates challenges.
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Dissolution Testing For Inhaled DrugsAlthough there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.
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Thermogelling Matrix-Containing Platelet Lysate-Loaded Elastic Liposomes as a Potential Treatment of WoundsThe purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.
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Molecular Properties of PROTACs and the Relationship to Formulation DesignAnalyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.
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Entering New Domains for 3D Printing of Drug Products3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
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Multivariate data analysis easily retrieves insight from a wealth of dataStatistics are often viewed as confusing and complicated, but multivariate data analysis (MVA) methods can be used to amass knowledge simply.
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How Integrated Project Delivery Enables Speed: A Phase-By-Phase GuideBy eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
