ISPE Product Quality Lifecycle Implementation® (PQLI®) Guide: Overview of Product Design, Development and Realization: A Science- and Risk-Based Approach to Implementation

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Published:October 2010
Pages: 44
Table of Contents ( 415 KB)

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This Guide is the first in a series of ISPE Product Quality Lifecycle Implementation (PQLI®) Good Practice Guides (GPGs) that will describe enhanced, quality by design approaches to product realization, and is an introduction to and an overview of the Guides Series. Product realization is the achievement of a product with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with marketing authorization), and internal customers’ requirements.

This Overview Guide and the subsequent ISPE PQLI GPG Series address product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches. Other Guides in the Series will cover:

  • Critical Quality Attributes and Critical Process Parameters
  • Design Space
  • Control Strategy
  • Illustrative Example using a Small Molecule Case Study

The Guide 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.


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