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Regulatory Focus™ > News Articles > Science & Technology: Product Quality Lifecycle Implementation

Science & Technology: Product Quality Lifecycle Implementation

Posted 01 September 2009

The International Society for Pharmaceutical Engineering (ISPE) launched its Product Quality Lifecycle Implementation (PQLI) initiative in June 2007 to help industry find practical approaches to the global implementation of recent quality guidelines published by the International Conference on Harmonisation (ICH): Q8(R1): Pharmaceutical Development (Revision 1), Q9: Quality Risk Management and Q10: Pharmaceutical Quality System. PQLI encompasses the entire product lifecycle and comprises three strategic themes: principles of quality by design; pharmaceutical quality system elements; and enablers (Figure 1). These strategic themes represent the key components of the ICH quality vision described at the July 2003 meeting in Brussels: "Develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science."


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