Authors
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Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning ValidationIn this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
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CROMAIMA is world leader in the design and manufacture of automatic machines and complete lines for the processing and packaging of pharmaceutical products.
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iMScope TRIOLatest:
Transforming Regulatory Data ManagementThe Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
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Addressing Security Risks in Connected OperationsA rigorous approach to industrial security is essential for protecting intellectual property and product integrity in connected pharmaceutical operations.
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Testing Water for Pharmaceutical UseUSP describes analytical and microbiology testing required for different types of pharmaceutical water.
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Innovation Boom TownsPartnerships between industry and academic medical centers are expanding to meet R&D needs.
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Understanding Fluidized-Bed GranulationThis study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
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Ensuring the Continuous Supply of Quality Drug Products During Uncertain TimesThe global coronavirus pandemic has tested the abilities of bio/pharmaceutical companies to develop new therapies and maintain-or even accelerate-production of existing drugs. In this webcast, experts will discuss business continuity practices, regulatory compliance, and supply chain management under current-or future-emergency conditions. Live: Tuesday, Apr. 28, 2020 at 11 am EDT | 10 am CDT | 8 am PDT On Demand: available after airing until Apr. 28, 2021 Register free
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Clean, Disinfect, and ValidateEffective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.
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Cold Chain Logistics for Personalized Medicine: Dealing With ComplexityThe complex packaging and logistics required for personalized medicine pose significant challenges, but proactive planning can help ensure success.
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Continuous Manufacturing: A Generic Industry PerspectiveThe pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
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Decoding Serialization RegulationsThe author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.
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Particle Size Reduction for Investigational New DrugsModern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.
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A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic SolutionIn this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic SolutionIn this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic SolutionIn this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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Extractables and Leachables Testing for Inhaled MedicinesFollow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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Overcoming Concerns to Adopting Continuous ProcessesDespite the benefits of continuous processing adoption has been slow, except for a few process areas.
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Working Smarter: Establishing an Effective Serialization ArchitectureThe author shares his opinion on the challenges presented by the Internet of Things and what companies need to consider when choosing suitable architectures to manage serialization data.
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Drug Spending Not Driving Rising Health Care CostsNew reports indicate that drug prices are slowing compared to other healthcare costs.
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Analysis of Sub-Visible ParticlesNovel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
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Patheon OneSource™Patheon OneSource™ helps small and emerging pharmaceutical companies lower risk and drive more predictable outcomes by integrating drug substance and drug product development decisions within a single CDMO.
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Construction Approach of a Phosgenation Laboratory and GMP Plant at ValsyntheseThe author describes the construction approach of a phosgene R&D laboratory and a medium-scale commercial phosgenation plant at Valsynthese.
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FDA Perspectives: Understanding Challenges to Quality by DesignDirectors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.
