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Top Stories
Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.
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The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.
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TOP COUNTRY FOR PHARMA?
What Country Ranks Highest in Pharma Manufacturing?
CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.
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Join Renishaw as we present a free day long symposium reviewing a variety of topics relevant to Raman in the Pharmaceutical Industry. Industry leaders from JEOL, Leica, Ondax, Linkam, and Renishaw will be presenting on the technology and techniques that impact the science of Raman today. The event takes place at Renishaw's Headquarters in West Dundee, IL on September 19.
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Industry News
The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.
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The agency published guidance on identifying trading partners under DSCSA.
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Supplier News
The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.
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Lonza announced an endothelial cell application center, which expands Lonza’s support for researchers.
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Bio/Pharma News
The private investment firm’s $110-million acquisition boosts its API and finished dosage form value chain.
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The antibody therapeutic failed to meet its primary endpoint in a Phase III study.
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Regulatory News
The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.
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FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.
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Quality
Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?
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Validation/Compliance
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
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Manufacturing
Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
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Events
September 11–13, 2017
September 19–21, 2017
September 25–29, 2017
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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