Pharmaceutical Technology Europe, Oct 1, 2010 - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Technology Europe, Oct 1, 2010
Special Feature
Developing A Quality Agreement Template For Single-Use Systems
By Jerold Martin
The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.
Validating Single-Use Systems
By Tony Hitchcock , George Saunders
There are a number of validation approaches that can be adopted for single-use systems — all of which incorporate an established approach.
The Pros And Cons Of Single-Use Systems
By Salavadi S. Easwaran
The willingness of the industry to use single-use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production.
Manufacturing
An All-Round Excipient For Direct Compression
By Reinhard Vollmer , Edmont Stoyanov
Using new co-processing technologies, the authors show that it is possible to formulate an 'all-round' excipient.
Regulation
Using Certified Reference Material To produce Compliant Water Purity Data
By Jeffrey C. Lowry
There are apparent inconsistencies between the use of these reference materials and the manufacture of the reference solutions that are actually used in the regulated test method.
EGA Position On The EC's Proposal For A Falisifed Medicines Directive
By Ilina Markova
Although the European Generic medicines Association (EGA) n has welcomed the European Commission's proposal for a Directive on the falsification of medicines, it has also identified subjects that are of specific relevance to the European generic medicines industry.
Ask the Expert
Online Monitoring Of Continuous Hot Melt Extrusion
By Jeffrey Hirsch
The advantages of coupling hot melt extrusion technology with online FT-NIR spectroscopy are explained.
Industry Insider
Europe: A Future Leader in Vaccines?
By Nathan Jessop
The early part of the decade saw a decline in vaccine sales and manufacture, but finally the industry is bouncing back, with Europe particularly well placed to make an impact.
Analytics
Quantitative open-access HPLC analysis: a new calibration approach
By Phil Borman , John Roberts , Barbara O'Reilly , Robin Attrill , Ian Barylski , Keith Freebairn
A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.
News
News
Innovative Medicines Initiative unfair to academia
Editor's Comment
Green is the word
By Fedra Pavlou
Every day we are exposed to messages of advice and guidance on what we can do to reduce the damaging effects that our lifestyles have on the environment.

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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
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Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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