PQLI Resources

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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.

ISPE Quality Metrics Initiative

At the request of FDA and under the sponsorship of ISPE’s PQLI group, an ISPE Quality Metrics working group has delivered a whitepaper to FDA identifying potential quality metrics acceptable to industry in support of risk-based inspections as called for in the US Food and Drug Administration Safety and Innovation Act (FDASIA). The recommendations contained in the paper stem from robust industry - FDA discussions facilitated by ISPE.

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.

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.

Last Update: 13 March 2014

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