PQLI® Program and Goals

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Through Product Quality Lifecycle Implementation® (PQLI® ), ISPE is spearheading the effort to provide ‘how to’ Good Practice Guides, and training materials supported by case studies for the implementation of these guidelines including a better understanding of the “enhanced, Quality by Design (QbD) approach.”

The first Guide entitled, “Overview of Product Design, Development, and Realization-a Science and Risk-Based Approach to Implementation,” has been published as a download and gives an overview of the application of Quality by Design (QbD) to product realization and acts as a top level roadmap for subsequent separate PQLI Good Practice Guides, covering various topics.

The Overview guide is part of a series entitled, ‘Product Realization using Quality by Design’, other guides in the series being:

  • Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs),
  • Design Space,
  • Control Strategy
  • Illustrative Example using a small molecule case study.

Subsequent Guides are being produced on important topics relevant to introduction and operation of a modern pharmaceutical quality system particularly supporting products and processes developed using enhanced approaches. Guides on Change Management System and Process Performance and Product Quality Monitoring System are being drafted. Leaders are evaluating potential topics and scopes for Guides on Process Validation, particularly given that the FDA Guidance on Process Validation has been issued.  Consideration will also be given to developing Guides for existing products, and small molecule and biotechnology-derived drug substances related to the ongoing ICH topic Q11, Development and Manufacture of Drug Substances.

How will PQLI achieve its Goals?

  • For established concepts (already well defined by guidelines and the Quality Implementation Working Group [Q-IWG] or after discussion): By delivering ISPE Good Practice Guides supported by case studies and training materials, extending the understanding to global audiences via workshops, presentations and webinars.
  • For concepts requiring discussion: Supporting further dialogue and discussion through conference presentations and workshops involving both industry and regulators.


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