(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released Parts 1 and 2 of a new series of good practice guides on product quality lifecycle implementation (PQLI). These guides comprise the official first and second volumes of a planned series of PQLI guides, which collectively address product and process development through a quality by design approach that covers the entire product life cycle. The series uses ICH guidelines Q8 (R2)—“Pharmaceutical Development,” Q9—“Quality Risk Management,” and Q10—“Pharmaceutical Quality System” as a basis, together with other relevant ICH guidelines.

“In recent years, both the industry and regulators have realized the importance of designing product quality into the process itself,” says PQLI project manager John Berridge. “Quality cannot be added during the testing phase; it must be built-in by design. The PQLI guide series gives industry personnel a road map for how to build quality into their processes, from product conception to continual improvement after the product is brought to market.”

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