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PQLI Resources
Product Quality Lifecycle Implementation® (PQLI®) is ISPE’s Global
Industry Initiative for a practical approach to implementation of International Conference on Harmonization
(ICH) guidances Q8 (R2), Pharmaceutical Development; Q9, Quality Risk Management; Q10, Pharmaceutical Quality
System; and Q11, Development and Manufacture of Drug Substances.
What is PQLI?
The Product Quality Lifecycle Implementation (PQLI) initiative resulted from the need to help industry find global solutions to implementation challenges of ICH guidances.
How will PQLI help me?
PQLI ...
- Describes practical application of new ICH quality guidances that underwrite the ICH quality vision
- Is about the many ‘hows’ relating to the ‘what’ of ICH guidances
- Demonstrates there are many right ways, not just one way, to successfully implement ICH guidances in a global environment and throughout the lifecycle of a product
- Focuses on science- and risk-based approaches to product realization and manufacture
- Welcomes contributions from all scientists, engineers, regulators, and industry leaders committed to supporting these principles
What does PQLI do?
Results are immediate, practical, and applicable. PQLI products are targeted at a wide spectrum of multi-disciplinary professional levels representing all stages of the lifecycle.
PQLI is building a set of resources useful to a broad spectrum of companies:
- Small, medium, and large innovators, generics
- Chemical and biotech, substance and product
- Global and regionally-based
ISPE welcomes input from all parties, yet its work products will not replicate activities underway by industry. For example please see information relating to our relationship with PDA and their Paradigm Change in Manufacturing Operations (PCMO™) program.
What has PQLI Delivered?
Product Quality Lifecycle Implementation® (PQLI®) Good Practice Guides (GPGs) provide information on global solutions to implementation challenges of ICH guidances.
- PQLI Guide: Overview of Product Design, Development and Realization: A Science- and Risk-Based Approach to Implementation
- PQLI from Concept to Continual Improvement Part 1: Product Realization using QbD, Concepts and Principles
- PQLI from Concept to Continual Improvement Part 2: Product Realization using QbD, Illustrative Example
- PQLI from Concept to Continual Improvement Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System
- ISPE Guide Series: Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement Parts 1, 2 and 3 - Special Offer for ISPE Members
- ISPE PQLI Guides Under Development
Classroom Training
Supporting Case Studies and Documents
PQLI Good Practice Guides reference other case studies and relevant documents in the public domain. Many thanks must be extended to the teams which produced these documents, names and company affiliations of members of these teams being available from the documents.
- European Federation of
Pharmaceutical Industries and Associations, Mock P2 (January 2006)
Produced in as an example of the Pharmaceutical Development (P2) section of a regulatory submission using the science and risk-based approach. This document was produced to promote discussion within industry and between regulators and industry of a small molecule tablet developed using wet granulation. - Pharmaceutical Development Case Study: “ACE Tablets”, prepared
by CMC-IM Working Group (March 2008) (
1 MB)
Produced as a Development Report for a small molecule tablet developed using the science- and risk-based approach using roller compaction. It is intended to help guide FDA and the industry toward the “desired state” of pharmaceutical quality envisioned for the 21st Century. - Quality Overall
Summary, Sakura Tablet, English Mock Quality Overall Summary (QOS), P2, PMDA work group (March 2009)
This is an example of the relevant parts of a Quality Overall Summary for submission to Japan MHLW for a small molecule tablet manufactured by direct compression and developed using the science- and risk-based approach. - A–Mab: A Case Study in Bioprocess Development, CMC Biotech
Working Group, version 2.1 (30 October 2009) ( 5 MB)
This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.
Curious about PQLI? View the “PQLI 101” Webinar - FREE to ISPE Members!
Learn about this important initiative. A webinar about the basics of PQLI is available on demand - free to ISPE Members, US$49.00 for non members.
Contact Us
To contribute, learn more, reach a member of the PQLI team, or get involved with PQLI, please email us at pqli@ispe.org.
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