Top ISPE Award goes to PM Group Experts

Tuesday 17 November 2009
The ISPE Journal, Pharmaceutical Engineering has named PM’s Alice Redmond and Nuala Calnan, together with Stan O’Neill (Compliance Group) as the winners of the ‘Article of the Year Award’, for their article ‘The FDA’s Draft Process Validation Guidance – Perspective from Industry’ published in May 2009.

The award was announcedat the ISPE annual meeting in San Diego. The ISPE’s annual Roger F. Sherwood ‘Article of the Year’ Award recognises the considerable contribution of authors to the ISPE’s journal throughout the year. Pharmaceutical Engineering articles are evaluated by a panel of volunteer reviewers according to a number of criteria, concentrating on the importance and timeliness of the subject matter and the quality of thepresentation. The usefulness to readers involved in improving the industry as well a improvements in knowledge andunderstanding of key topics were also considered.
Alice and Nuala’s article provided an overview of the draft guidance, the key changes in relation to the 1987 Guidance, and reviewed its potential impact on the current industry approaches to science and risk-based design and qualification activities, which support the process validation program.

Click here to read the article

Click to view Alice Redmonds biog