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New Reduced price! ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 - Product Realiz

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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 - Product Realiz

Reference: M00002180

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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

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

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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.

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Published: 11/01/2011 ISBN(s): 9781936379231 Number of Pages: 232 File Size: 1 file , 15 MB