Product Quality Lifecycle Implementation Guide: Product Realization Illustrative Example

Product Quality Lifecycle Implementation Guide: Product Realization Illustrative Example cover image

Title:

Product Quality Lifecycle Implementation Guide: Product Realization Illustrative Example

Author(s):

Ahuja, Eric; Alexander, Brett; Bryder, Mette; Busse, Sue; Cook, Graham; Davis, Bruce; Donaubauer, John; Groskoph, John; Hopkins, Sandy; Kourti, Theodora; Kraemer-Hansen, Mette; Lepore, John; Lundsberg-Nielsen, Line; Nosal, Roger; Potter, Christopher, PhD; Stott, Paul; Tyler, Stephen; Watson, Timothy

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Author(s): Ahuja, Eric; Alexander, Brett; Bryder, Mette; Busse, Sue; Cook, Graham; Davis, Bruce; Donaubauer, John; Groskoph, John; Hopkins, Sandy; Kourti, Theodora; Kraemer-Hansen, Mette; Lepore, John; Lundsberg-Nielsen, Line; Nosal, Roger; Potter, Christopher, PhD; Stott, Paul; Tyler, Stephen; Watson, Timothy

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.

Table of Contents

Product Quality Lifecycle Implementation Guide: Product Realization Illustrative Example

Full Title: ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example
Pages: 232
Published: 2011-11-01