Pharmaceutical Technology Europe-10-01-2010

There are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.

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.

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.

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.

Innovative Medicines Initiative unfair to academia

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.

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.

The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.

The advantages of coupling hot melt extrusion technology with online FT-NIR spectroscopy are explained.

Using new co-processing technologies, the authors show that it is possible to formulate an 'all-round' excipient.

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.

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.