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ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases

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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 – Product Realization using QbD, Illustrative Example

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Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011

Description

Part 2 presents the small molecule case study developed by the ISPE PQLI® teams. This case study provides details of the application of the approaches to product and process understanding using quality risk management. Part 2 also refers to the many case studies in the public domain and uses ICH guidelines Q8 (R2), Q9, Q10, together with other relevant ICH guidelines.