NEW: PQLI releases Draft PQLI Summary Update Report
The PQLI Vision
The Product Quality Lifecycle Implementation (PQLI) initiative was launched in June 2007 to help industry find practical, global approaches to implementing ICH guidance's. Through PQLI, ISPE is spearheading the effort to define terminology contained in the ICH documents, to provide the technical framework required for the implementation of Quality by Design (QbD) in regulatory submissions, and to enable Q8, Q9, and the imminent Q10 (Pharmaceutical Quality Systems) to become cross-functional tools valued by both the Industry and Regulatory Authorities worldwide.
PQLI is projected to be at least a five-year initiative that has started with highly interactive fact-gathering sessions held in locations in the three ICH regions; with working groups that will continue to collect and process that information for distribution as white papers; resulting in articles to be published in ISPE’s Journal of Pharmaceutical Innovation and Pharmaceutical Engineering Magazine; and eventually with more detailed technical documents; and well as training programs that will be produced by ISPE for the industry worldwide.
How PQLI Benefits You
The industry-driven PQLI initiative is a conduit for you, the pharmaceutical professional, to express your views and concerns to regulators regarding these critical issues, and to hear back from the regulators regarding your input. PQLI attendees have a unique opportunity to provide the input that will help craft a pragmatic approach to implementing Q8, Q9, and ultimately Q10.
Attendees at any PQLI session gain access to the PQLI Work Space where presentations, proceedings, white papers and discussions are hosted.
The Short View and the Long
- 1st year
- Vision and road map development
- Workshops, white papers, articles generation
- Dissemination through the “Journal of Pharmaceutical Innovation”
- 2nd & 3rd years
- Seek input to support development of regulatory guidance
- Seek input to support global regulatory objectives
- Creation of an ISPE PQLI “how to” / “encyclopedia of QbD” good practice guides
- Task Teams of Subject Matter Experts (SMEs) provide training at key ISPE meetings / distant learning offerings as well as contribute as thought leaders for other organization events
Upcoming PQLI sessions
PQLI Steering Committee (SC) members and Subject Matter Experts (SMEs) have worked together to develop the initiative for the industry, including:
- Ronald Branning (Chair, SC)
- Robert Baum, PhD (PhRMA Advisor, SC)
- John Berridge, PhD (EFPIA Advisor, SC)
- Bruce Davis (Technical Team Leader, SME)
- Paul D’Eramo (SC)
- Charles P. Hoiberg, PhD (SC)
- John Lepore (Technical Team Leader, SME)
- Line Lundsberg, PhD (Technical Team Leader, SME)
- George Millili, PhD (SME)
- Gert Moelgaard (SME)
- Roger Nosal (Technical Team Leader, SME)
- Joseph X. Phillips (SC)
- Christopher Potter, PhD (Technical Team Leader, SME)
- Thomas W. Schultz, PhD (Technical Team Leader, SME)
- David W. Selby, PhD (co-chair, SC)
- Russ Somma, PhD (SC)
- James Spavins (Technical Team Leader, SME)
- Robert W. Tribe (Advisor, SC)
Complete information on the upcoming PQLI session in Copenhagen
