May 6, 2015
Volume 11 Issue 5
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API Synthesis & Manufacturing
Cynthia A. Challener
FDA steps up inspections of foreign API manufacturers, thanks to new legislation and changes in policy.
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FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.
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Solid Dosage and Excipients eBook
Pharmaceutical Technology's 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
Read/Download Now
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Paul Kippax and Deborah Huck-Jones
Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients, separately and when combined during oral solid dosage formulation and development.
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Actionable Intelligence for Pharma Sourcing
Are you are a pharmaceutical company with sophisticated sourcing needs? Or a biotech company looking for API/dose manufacturers? PharmSource provides timely, reliable intelligence and essential insights that will help you advance your business goals.
Learn more about  PharmSource STRATEGIC ADVANTAGE today. |
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Outsourcing Update
Jim Miller
Big service providers get bigger faster thanks to Big Pharma.
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Colin MacKay
The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
Live Webinar: Thursday, May 14, 2015 at 8 am PDT/ 11 am EDT/ 4 pm BST/ 5 pm CEST
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to
learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
 Register Here
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Supply Chain Management
Agnes Shanley
As a special session at Interphex 2015 made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk.
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CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.
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Regulation & Compliance
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
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Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.
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Contract Services Report
Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.
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IDT Biologika receives 2015 Facility of the Year Award for facility integration from ISPE.
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Stability testing and UPLC capabilities highlight expansion at Mumbai, India facility of SGS Life Science Services.
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Rentschler Biotechnologie expands European manufacturing capabilities with GE Healthcare Life Sciences bioprocess technologies.
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Recipharm makes a strategic investment in Synthonics and partners in development of novel compounds.
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Webcasts
Wednesday, May 27, 2015 at 11AM ET
With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by: Mettler Toledo
Thursday, May 21, 2015, 11 am EDT
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Sponsored by: Patheon
more webcasts
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