Authors
Latest:
Integrating Powder Characterization into Raw Material Selection and Process OptimizationAs tests at GSK have shown, integrating powder testing into overall operations can optimize process understanding, and with it, raw material selection, equipment design, and process development.
Latest:
Inhalation Drug Delivery: The Impact of Particle Size ReductionResearch compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
Latest:
Inhalation Drug Delivery: The Impact of Particle Size ReductionResearch compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
Latest:
Inhalation Drug Delivery: The Impact of Particle Size ReductionResearch compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
Latest:
Transform Your Lab Workflows and Resource Utilization***December 8, 2020 at 10am EST| 3pm GMT| 4pm CET*** Join this live webcast to learn more about a unique and powerful integration between lab scheduling and lab procedure execution, leading to an 80% reduction in time spent planning and organizing work as well as 10x reduction in compliance risk through standardized processes..*** On demand available after final airing until Dec. 8, 2021.***
Latest:
The PDA Pharmaceutical Microbiology Conference: The Hottest Ticket in the IndustryGet a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Latest:
Specification Equivalence—A Practical ApproachIn this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
Latest:
Specification Equivalence—A Practical ApproachIn this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
Latest:
Supply-Chain Security from a European PerspectiveGlobal harmonisation would help improve supply-chain security and reduce the flow of falsified and sub-standard medicine into Europe.
Latest:
In-line Laser Marking of Silicone TubingPharmaceutical companies require marked components for lot traceability but problems occur within secondary processing and with traditional printing methods.
Latest:
Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
Latest:
Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
Latest:
Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
Latest:
Automation on Display at Healthcare Packaging ExpoAutomated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.
Latest:
Uncovering Hidden Risks in Solid-State API PropertiesAn understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.
Latest:
Planning a Successful API Procurement StrategySourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
Latest:
Planning a Successful API Procurement StrategySourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
Latest:
Planning a Successful API Procurement StrategySourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
Latest:
Getting in Touch with New Guidance on Topical ProductsChanging regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.
Latest:
Using Software in Process ValidationSoftware systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
Latest:
GalenIQ™ - The sweet filler - binderBENEO is a division of the Südzucker Group, that employs more than 1000 people and has production units in Belgium, Chile, Germany and Italy.
Latest:
Solving Pharma’s Quality Unit Identity Crisis483s and Warning Letters Point to Inadequate Quality Oversight
Latest:
Lessons from FDA 483s and cGMP Inspection DataProduction and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
Latest:
Assessing Legacy Drug QualityA data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
Latest:
Optimizing Manufacturing Based on the Storage Stability of Pegylated ProductsResearch into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
Latest:
Optimizing Manufacturing Based on the Storage Stability of Pegylated ProductsResearch into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
Latest:
Optimizing Manufacturing Based on the Storage Stability of Pegylated ProductsResearch into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
Latest:
DWK Life SciencesDWK Life Sciences, represented by SciLabware (a wholly owned company of DWK Life Sciences), manufacture and supply a complete portfolio of standard and bespoke primary packaging solutions and services that meet and exceed the rigorous requirements and expectations of our customers. From tubular glass vials, stoppers and caps for lyophilisation and diagnostic kits, glass tubes and caps for control reagents, dropper bottles, with dropper assemblies or tips and closures for blood grouping reagents and rare antisera, to additional services including depyrogenation, particulate cleaning and barcoding, we can offer our customers a full primary packaging solution, received ready to use.
Latest:
Replacing Settle Plates with Active Air SamplingJoin this discussion with experts about implementing active air microbial monitoring in sterile cleanrooms. Learn about changes that can save time and money and reduce the risk of product contamination. Live: Wednesday, Nov.13, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET On demand available after airing until Nov. 13, 2020 Register free
Latest:
The Essential Guide: Cleanrooms and Clean AreasAt Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology, and the latest trends in the industry.
