Monday, June 02, 2008

ISPE says quality programme starts to bear fruit

The International Society of Pharmaceutical Engineers has reported the first findings of a five-year new programme aimed at working tackling one of the toughest problems in pharma manufacturing at present - how to implement the new quality systems model laid out by the International Conference on Harmonization.

The first fruits of that programme, published in the June edition of the Journal of Pharmaceutical Innovation, represent a preliminary stage in attempting to provide practical guidance on how to implement these concepts into pharmaceutical processes.

Dubbed the Product Quality Lifecycle Implementation (PQLI), it was designed by ISPE as an initiative to help pharmaceutical manufacturers meet the requirements of ICH Q8, Q9 and Q10 in a way that would be acceptable to regulatory authorities.

link to full article

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