Roadmap of PQLI® for 2009-10 and Beyond
Product Quality Lifecycle Implementation®(PQLI®) teams continue to develop
materials supporting the realization and implementation of the ICH quality vision.
- Papers for comment
- Conference presentations at ISPE meetings
- Conference presentations in collaboration with other groups
- Workshops and Webinars
Activities focus in two main areas:
- For established concepts (already well defined by guidelines and ICH Quality Implementation
Working Group (IWG) ):
By supporting and complementing implementation topics with practical case studies, training,
extending the understanding to global audiences, preparation of ISPE Good Practice® Guides and similar
technical guides, etc.
- For concepts requiring discussion:
Supporting further dialogue and discussion through papers, conference presentations, and workshops
involving both industry and regulators.
Future PQLI Products
- The practical application of the new ICH quality guidelines that underwrite the ICH quality vision
through conference presentations, workshops, ISPE documents, and training courses.
- A range of the many ‘hows’ relating to the ‘what’ of ICH guidelines through phased delivery of an ISPE
- Examples demonstrating there are many right ways to successfully implement the ICH guidelines in a global
environment and throughout the lifecycle of a product.
- A relentless focus on science- and risk-based approaches to product realization and manufacture.
- Contributions from all audiences including scientists, engineers, and regulators, committed to supporting
- Global delivery and expansion of Task Teams.
The Short View and the Long
Work completed to date
Vision and Purpose:
- Workshops held that led to white papers published in the Journal of Pharmaceutical Innovation
(June 2008) on ‘Criticality’ (now called ‘Critical Quality Attributes and Critical Process Parameters’);
‘Design Space’ and ‘Control Strategy;’
- Paper, ‘Application of Science- and Risk-based Approaches (Q8, Q9 and Q10) to Existing Products’ in the
Journal of Pharmaceutical Innovation (March 2009);
- ISPE is hosting the final version of the CMC-Biotech Working Group consortium case study entitled
- The PQLI Roadmap, the first Guide in the Good Practice Guide Series, ‘Product Design, Development, and
Realization-A Science and Risk-Based Approach to Implementation’ has been completed by the PQLI team and has
been reviewed by ISPE COPs and Affiliates. The other Guides in the Series are actively being progressed by
Next One to Three years
- The A-Mab case study ( 5 MB) is being used by PQLI in workshop
and discussion sessions.
- Completion of the ISPE PQLI Good Practice Guides
Series will include, as individual Guides, a Q8(R2)/Q9/Q10 implementation overview (Roadmap), updated
Guides on Critical Quality Attributes and Critical Process Parameters (CQAs/CPPs), Design Space and Control
Strategy supported by a small molecule case study Guide and using the concepts in the A-Mab Biotech case
study (see the figure below showing how the Guides relate to each other).
- Task Teams of Subject Matter Experts (SMEs) will provide updates and findings at key global ISPE meetings
and via webinars, as well as contribute as thought-leaders for other organization events.
- Expand PQLI to have more discussion and input to implementation of Pharmaceutical Quality System topics
potentially leading to additional PQLI Good Practice Guides.
- Liaise with ISPE Communities of Practice (COPs) and Affiliates to consider and initiate other topics such
as Development and Manufacture of Drug Substances after ICH Q11 is published, and knowledge/data
The PQLI program and approach is summarized in the following four figures. The work flow is given in the
first figure, the science- and risk-based approach to implementation of Q8(R2), Q9 and Q10 is given in the
second figure, the structure of the GPG Guide Series is given in the third figure and the phased delivery of
Guides and potential future topics is summarized in the fourth figure.
PQLI Welcomes New Proposals
The Foundation of PQLI: Quality by Design Flow
PQLI Good Practice Guide Series: Product Design, Development, and Realization, a Science- and
Risk-Based Approach to Implementation
ISPE Good Practice Guide Phased Delivery