Pharmaceutical Technology Europe, Dec 1, 2010 - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Technology Europe, Dec 1, 2010
Special Feature
Are Cleanroom Regulations Realistic?
By Jim Agalloco
What are the current expectations for cleanroom operations? And are these realistic?
Passing Cleanroom Inspections
By Jeanne Moldenhauer
A review of warning letters from the last 10 years relating specifically to cleanrooms has indicated several concerns with the appropriateness of cleanroom design — primarily regarding air flow and laminarity.
Selecting The Right Cleanroom Solutions
By Mark Dalziel
Contamination in all its forms should be identified and reduced whenever and wherever possible.
Regulation
Managing Staff Training And GMP Compliance
By Monika Brunn
A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.
Manufacturing
Lean Compliance And Adopting A True Risk-Based Approach To Validation
By Mark Stevens
With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.
Industry Insider
Europe Addresses Antibiotic Resistance
By Nathan Jessop
A European-wide awareness initiative hopes to tackle the issue of antibiotic over-prescription, but industry must also be encouraged to make further investments.
News
News
Biotech has had a profound impact on the pharma industry by helping to develop new medicines that treat patients more effectively; however, despite its achievements, it hasn't made a significant difference to the number of new treatments reaching the market.
Editor's Comment
A year of ups and downs
By Fedra Pavlou
So 2010 is nearly over and what a year it's been for our industry.

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Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
20%
Attracting a skilled workforce
28%
Obtaining/maintaining adequate financing
12%
Regulatory compliance
40%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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