Pharmaceutical Technology Europe - April 2012 - (Page 12)

BLOGS ABRIDGED International GMP collaboration Medicine regulatory agencies in the EU, US and Australia have been successfully collaborating for some time now with regards to GMP inspections of API manufacturers, but now they are seeking to further expand this international effort by looking to include additional partners. The initial pilot scheme ran from 2008 to 2010 and involved the sharing of inspection plans, reports and information concerning API manufacturers, as well as several joint inspections. The project was so successful that cooperation in these areas has continued. The current partners have agreed that clear criteria need to be established for any new participant to be accepted, as well as to maintain ongoing participation. To this end, the EMA has published a document entitled Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers that outlines the terms of reference and procedures for authorities to participate in the programme. http://blog.pharmtech.com/2012/03/09/expanding-international-gmpcollaboration/ GSK causes UK celebration GlaxoSmithKline this has given the UK government and several trade organisations reason to celebrate after announcing that it will build a new manufacturing facility in the country — the first in almost forty years. The facility will be dedicated to biopharmaceuticals and will create new jobs in Ulveston, Cumbria, which has been chosen for the new site. Construction is estimated to cost £350 million and is anticipated to begin in 2014 or 2015. It is expected to take at least 6 years before the facility is fully operational. In addition, GSK will make investments at other UK manufacturing sites in Montrose and Irvine (Scotland), Ware (Hertfordshire) and Barnard Castle (County Durham). Overall, the company will invest more than £500 million and create up to 1000 jobs. In a nod to the environment, some of the funding will be dedicated to environmentally friendly manufacturing technologies. http://blog.pharmtech.com/2012/03/23/gsk-causes-uk-celebration/ 2 SPECIAL FEATURE 14 MAGNETIC VECTORING 3 LYOPHILISATION EXPERTS 15 COLUMNS 12 BLOGS 17 DRUG IMPURITIES 14 MAGNETIC VECTORING 18 TOP TECH http://blog.pharmtech.com/2012/03/09/expanding-international-gmp-collaboration/ http://blog.pharmtech.com/2012/03/09/expanding-international-gmp-collaboration/ http://blog.pharmtech.com/2012/03/23/gsk-causes-uk-celebration/

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - April 2012

Pharmaceutical Technology Europe - April 2012
Contents
Thoughts and challenges connected to design space and Quality by Design for lyophilisation processes
News Bites
Blogs Abridged
Interview: Achieving localised delivery with magnetic vectoring
Column Crunch: Greek healthcare system, outsourcing, packaging and excipient portfolios
Evaluating drug impurities
Top Tech

Pharmaceutical Technology Europe - April 2012