Authors
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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
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Innovations in Parenteral Medicines PackagingParenteral drugs are becoming increasingly complex, creating new challenges and opportunities. This paper explores potential innovations across the entire value chain.
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Challenges Of Particle CharacterisationParticle characteristics can affect pharmaceutical formulations and products in a number of ways, and a variety of techniques are available that enable particle monitoring and characterisation.
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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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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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Why Syringes Continue To Dominate The Parenteral Drug Delivery MarketThe application of the first piston syringes to treat medical complications was described in Roman times during the 1st century, and forms of intravenous injection and infusion began as early as 1670.
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Assessing Legacy Drug QualityA data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
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Current Trends in Host Cell Protein Detection for Biologics ManufacturingIn this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Review of FDA Warning LettersThe author reviews Warning Letters issued between 2000 and mid-2010 for aseptic processing and non-sterile processing, and determines how many observations were made for each section of the GMPs.
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A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing ProcessResearchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
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Part 1 of 4: Pharma 4.0 and Digital TransformationAn Overview with Aubrey Hogan Verista’s Head of Regulatory Compliance and Product Lifecycle Management
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QPSHARE: a new way to share auditsShared audits of suppliers offer several advantages, but networking to conduct such an audit can be challenging.
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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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How Regulatory Oversight Protects CBD ConsumersMany consumers trust that a Certificate of Analysis (COA) guarantees product safety, but without strict regulatory oversight, that’s not always the case. This white paper provides insights into what consumers and businesses should look for in a truly safe, high-quality, and consistent product.
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DSCSA’s Next Big HurdleInteroperability by 2023 depends on data standardization and systems compatibility between trading partners.
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Guest Editorial: Interphex Focuses on Evolution of the Life SciencesShow blasts off this month in Philadelphia with more suppliers, new trends, and real-world solutions.
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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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Lab Digitalization: From Source to ScientistIntegrating digital technologies into lab environments can ease workflow and enhance data capture for researchers.
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Challenges When Outsourcing Viral Safety ServicesAssessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
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Continued Process Verification for Cleaning Validation– Challenges and PitfallsContinued process verification for a cleaning validation program begins once the validation study is complete.
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Delivering on the Potential of mRNA TherapeuticsThe complexity of the RNA production process creates challenges.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Optimizing Quality by Design in Bulk Powders and Solid DosageCase studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.
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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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Converging InformationTechnology & Automation TeamsGetting IT, engineering, and manufacturing on the same page requires a delicate balance.
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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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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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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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Continuous Mixing of Solid Dosage Forms via Hot-Melt ExtrusionThe author describes the benefits, processes, and practicality of using hot-melt extrusion to mix active pharmaceutical ingredients with pharmaceutical-grade polymers.
