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Important: Part 3 is only available as an individual download. Select Bound Version to get bound versions of Parts 1 and 2, with Part 3 delivered as a download.
Parts 1, 2, and 3 of the ISPE Product Quality Lifecycle Implementation® (PQLI®) Guide Series describe the concepts and principles of Quality by Design (QbD), the potential product lifecycle approaches to the change management system element of a pharmaceutical quality system, and provide an example practical approach on how to implement QbD principles for an oral solid dosage product containing a small molecule.