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Top Stories
After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
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The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.
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The 2017 PDA/FDA Joint Regulatory Conference is the premier pharmaceutical manufacturing event where you can engage directly with U.S. FDA representatives! Over two and a half information-packed days, FDA regulators will provide updates on efforts affecting the development of global regulatory strategies, and industry experts will illustrating how they use global strategies to improve the quality of medical products.  Learn more and register! |
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Industry News
The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.
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The assay assesses the ability of antibodies to neutralize the Ebola virus.
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Supplier News
The suite installation increases PCI's Hay-on-Wye site's serialization capability to support clients in advance of meeting the implementation dates of the European Falsified Medicines Directive.
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Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.
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Changing the functional role of capsules in drug delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsule and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. Capsugel provides leading-edge solutions that protect high value compounds, optimize delivery to targeted sites in the body, and ensure the best operational performance in capsule filling. To learn more, visit  www.capsugel.com. |
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Fresenius Kabi has added two new antibiotics production lines at its plant in Santiago de Besteiros, Portugal.
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Connect Upstream for Robust Production
Mitigate raw material virus contamination risks with our new virus media filter. Eliminate cell growth concerns with Flexsafe® bags. Rely on proven stirred-tank design enhanced with single-use biomass measurement. Benefit from robust single-use clarification for up to 2000 L high performance fed-batch processes.  Learn more |
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Regulatory News
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
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The agency's Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
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Manufacturing Executive Systems (MES) 8/8-9 pc17144
Packed with breakthrough content and next-generation strategies, CBI's MES 2017 is dedicated to providing tangible insight on innovative applications and processes to master this advanced IT-based solution. Collaborate with peers and share prevailing industry approaches to ensure manufacturing intelligence and excellence by successfully deploying, integrating, maintaining and utilizing data from MES. Ensure your organization is achieving the highest ROI on its MES activities.  Learn more |
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MANUFACTURING
Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.
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Data Integrity Validation 8/16-17 pi17123
IVT's Data Integrity Validation provides a variety industry perspectives in an unmatched working-group environment. This year's conference delves into the nuances of building and maintaining a compliant data integrity program across company-wide systems.
With over a year of adjusting to FDA's Data Integrity Guidance underway, take this opportunity to reconvene with your peers and benchmark processes to ensure a data integrity culture throughout your organization.
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QUALITY
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Events
August 15–16, 2017
August 16–17, 2017
August 21–25, 2017
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REFERENCE BOOKS |
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A compilation of articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products.
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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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