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PQLI logo 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, 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.

See Who's Involved in PQLI

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

More on how PQLI can Help You

Learn with, and contribute to, industry colleagues and regulators by attending upcoming meetings, seminars, and workshops including:

PQLI/PAT - Moving Beyond ICH Q8, 9, and 10 Concepts: Biotech QbD Realization Case Studies Leveraging PAT

8 November 2011
ISPE 2011 Annual Meeting
Gaylord Texan Resort & Convention Center
Dallas/Fort Worth, Texas, USA

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 is PQLI Delivering?

An ISPE PQLI Good Practice Guide (GPG) Series will be delivered in volumes. The first volume is entitled ‘Product Realization using Quality by Design’ (previously ‘Product Design, Development, and Realization, a Science- and Risk-Based Approach to Implementation’), including the recently released Overview. This volume contains a series of individual GPGs:

Overview of Product Design, Development, and Realization
Critical Quality Attributes and Critical Process Parameters
Design Space
Control Strategy
A small molecule Illustrative Example

A second volume entitled, ‘Pharmaceutical Quality System’ will consist of two GPGs as follows:

Change Management System
Process Performance and Product Quality Monitoring System

Leaders are evaluating potential topics and scopes for Process Validation with the intention if there is sufficient interest in developing Guides.

A Biotech team is developing a Guide to extend and expand the concepts discussed in the A-Mab case study.

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.