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Are You Ready for Inspection?Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.
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Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
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Retirement for Obsolete Heavy Metals TestsThis article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
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Retirement for Obsolete Heavy Metals TestsThis article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
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Retirement for Obsolete Heavy Metals TestsThis article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
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Methods for the Automated Manufacturing of an Autologous Dendritic-Cell ImmunotherapyThe authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.
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Risk-Averse Fill/Finish Industry Embraces ChangeSingle-use technologies, modular systems, and robots are on the rise.
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Risk-Averse Fill/Finish Industry Embraces ChangeSingle-use technologies, modular systems, and robots are on the rise.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Cleaning Chromatography Resin Residues from SurfacesLaboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Sartorius In-Line Lysis System: The Easiest Alternative to Batch Alkaline LysisWebinar Date/Time: Tue, Jun 11, 2024 10:00 AM EDT
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Preventing Microbial Contamination of Viral Vaccines and VectorsThe risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.
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Preventing Microbial Contamination of Viral Vaccines and VectorsThe risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.
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Preventing Microbial Contamination of Viral Vaccines and VectorsThe risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.
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Preventing Microbial Contamination of Viral Vaccines and VectorsThe risks of microbial contamination inherent in the production of viral vaccines and viral vectors used in biotherapeutic applications must be addressed.
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Viewpoint: The Driver of Drug DeliveryAdvances in medicine and consumer electronics can enhance drug delivery and patient care.
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Third-Party Audits: Ensuring That Excipients Meet cGMP RequirementsIncreasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
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Third-Party Audits: Ensuring That Excipients Meet cGMP RequirementsIncreasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
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Third-Party Audits: Ensuring That Excipients Meet cGMP RequirementsIncreasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
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Understanding Excipient Characteristics to Ensure Robust Continuous ManufacturingKey information is needed for excipients and their potential impact on continuous manufacturing processes.
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Planning a Successful MES DeploymentPreventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.
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Hard Capsules as a Flexible Dosage FormInnovations in hard-capsule technology enhance the flexibility that hard capsules can provide for dosage forms.
