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Pharmaceutical Technology Europe-10-01-2010
Pharmaceutical Technology Europe
Validating Single-Use Systems
October 01, 2010
Special Feature
22
10
There are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.
EGA Position On The EC's Proposal For A Falisifed Medicines Directive
October 01, 2010
Regulation
22
10
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.
Green is the word
October 01, 2010
22
10
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.
Using Certified Reference Material to Produce Compliant Water Purity Data
October 01, 2010
Regulation
22
10
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.
The Pros And Cons Of Single-Use Systems
October 01, 2010
Special Feature
22
10
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.
Europe: A Future Leader in Vaccines?
October 01, 2010
Industry Insider
22
10
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.
Developing A Quality Agreement Template For Single-Use Systems
October 01, 2010
Special Feature
22
10
The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.
Online Monitoring Of Continuous Hot Melt Extrusion
October 01, 2010
Ask the Expert
22
10
The advantages of coupling hot melt extrusion technology with online FT-NIR spectroscopy are explained.
An All-Round Excipient For Direct Compression
October 01, 2010
Manufacturing
22
10
Using new co-processing technologies, the authors show that it is possible to formulate an 'all-round' excipient.
Quantitative open-access HPLC analysis: a new calibration approach
October 01, 2010
Analytics
22
10
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.
Braille packaging & European generics growth
October 01, 2005
Manufacturing
22
10
Adding Braille to pharmaceutical packaging should be less of a challenge with the use of Esko-Graphics' Scope solution. EC Directive 2004/27/CE requires Braille labelling and information to be provided with pharmaceutical products for human use, and companies are scrambling to implement this by 31 October.