Product Quality Lifecycle Implementation
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 and Q10, Pharmaceutical Quality System, as well as the more recently initiated topic, Q 11, 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 ...
|
Learn with, and contribute to, industry colleagues and regulators by attending upcoming meetings, seminars, and workshops including:
|
What does PQLI do?
ISPE welcomes input from all parties, yet its work products will not replicate activities underway by industry. For example please see the latest news relating to our relationship with PDA and their Paradigm Change in Manufacturing Operations (PCMO) program.
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
What is PQLI Delivering?
An ISPE PQLI Good Practice Guide (GPG) Series will be delivered, including the first to be released, PQLI Roadmap, “Product Design, Development, and Realization, a Science- and Risk-Based Approach to Implementation”. The series will consist of the following:
- PQLI Roadmap
- Critical Quality Attributes and Critical Process Parameters
- Design Space
- Control Strategy
- A small molecule Illustrative Example
A Biotech team is developing a Guide to extend and expand the concepts discussed in the A-Mab case study.
More information on the Program and
Goals …
View details of the PQLI Roadmap
…
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.
More information and document downloads
…
Curious about PQLI®? Download the “PQLI 101” Webinar - FREE to ISPE Members!
Learn about this important initiative. A “PQLI Basics” webinar about the basics of PQLI is available on demand. ISPE Members are able to view it for free. Nonmembers will be charged a nominal fee.
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.