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  Pharmaceutical Technology Europe E-Alert
 
16 December 2011

IN THIS ISSUE
Novartis warning letter
EMA–FDA joint inspections
Ben Venue quality
AstraZeneca in China

 
FDA warns Novartis of violations at three plants
In a Warning Letter, the FDA has cited  “significant violations” of cGMP regulations, including several repeat  observations, at three Novartis facilities. More...
 
FDA–EMA joint manufacturing inspections begin in New Year
The FDA and EMA are moving from “confidence-building to reliance upon” each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer. More...
 
EMA addresses Ben Venue quality issues
After reviewing the “shortcomings in quality assurance” that were recently identified at Ben Venue Laboratories’s Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta and Liminity. More...
 
AstraZeneca to expand presence in China
AstraZeneca has entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in China for an undisclosed amount. More...
 
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Key Topics:
Latest blog posts
Is HHS using scientific standards?
Scaling the bioprocess barricade
FDA inches towards a biosimilar approval pathway
More blog posts

PTE Digital
Avoiding contamination risks in aseptic processes
The impact of single-use systems
Changing demand for modular cleanrooms
Read the full issue

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PepTalk 2012 (9–13 January | USA)
European Pre-Filled Syringes (18–19 January | UK)
Cool Chain Logistics Europe 2012 (30 January–1 February | Switzerland)
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Products/Service Profiles
Sepha

VisionScan: a tool-less, non-destructive leak detection device for pharmaceutical blister packs.  Using high resolution imaging technology, it offers pharmaceutical manufacturers a flexible, reliable, objective and cost saving alternative to destructive test methods.
Read more

 
Survey
Do you support a generic-drug user fee for industry?
Yes 61%
 
No 39%

This week we would like to know...

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