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Martin Warman - Articles and news items

PAT Roundtable: trends and issues

Issue 1 2009, Past issues / 7 February 2009 /

European Pharmaceutical Review invited four individuals to discuss their views and opinions on current trends and issues surrounding PAT.

2008 PAT Initiative Review

Industry Focus 2009, Past issues / 10 January 2009 /

As the industry approaches the five year anniversary of the ground breaking regulator initiatives (the ‘PAT framework’ and ‘cGMPs for the 21st Century’1,2), it is time to assess the impact they have had on the industry and to look forward to what the industry may look like in another five years time. In some ways the initiatives need to be considered as ‘facilitators’, enabling the business driven activities (which had already started in many pharmaceutical companies) to flourish; these activities, driven by reducing risk by increased process understanding, were already common in other advanced manufacturing industries.

 

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