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20 JUNE 2007

ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, launched a new initiative called Product Quality Lifecycle Implementation (PQLI) at its Washington Conference in early June...

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SPE Launches PQLI Initiative to Facilitate Implementation of ICH Q8 and Q9 Guidelines 


ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, launched a new initiative called Product Quality Lifecycle Implementation (PQLI) at its Washington Conference in early June.

In its role as a “catalyst for change” ISPE is working with regulators in the United States, Europe, and Asia-Pacific to help industry find solutions to the challenges in implementing ICH guidances. The goal of these sessions is to begin to define areas where industry will be able to provide the technical framework for the implementation of QbD in regulatory submissions.

The first PQLI session held in Washington attracted more than 230 participants from most of the major pharmaceutical companies. The two-day session offered an exclusive opportunity for industry leaders from science, manufacturing, quality, and engineering to engage with the US Food and Drug Administration (FDA), discuss real world solutions, and help craft a pragmatic approach to implementing Q8 and Q9.

“The uptake by industry on this initiative has been incredible and quite gratifying to all our team members,” said Russ Somma, PhD, Project Team Chairman and Steering Committee member. “The energy at the Washington inaugural session confirmed just how important this initiative is to the industry.”

A working group will continue to monitor progress, collect information and process into white papers, guidances, and technical documents. Teams and working groups will gather again in September in Berlin, Germany for another working session. Additional sessions in November in Las Vegas, Nevada, USA; and Copenhagen, Denmark in April 2008 will provide updates and opportunities for global views from within the industry to get understanding of challenges.

PQLI examines Q8 and Q9 and identifies the subjects/terms that need to be further elaborated, and explains why there is a need for a clarification. Six highly interactive workshops focused on NCEs (vs. biotech drugs) and covered API Design Space, DP Design Space, API Critical vs. Non-Critical, DP Critical vs. Non-Critical, API Control Strategy Traditional vs. Quality by Design (QbD), and DP Control Strategy Traditional vs. QbD.

“ISPE’s PQLI provides the linkage between the high level ICH guidelines and the needs of those wanting to implement them. These sessions are critically important opportunities to understand the latest developments from those directly involved in ICH and to contribute to clarifying the issues and opportunities of implementation,” according to John Berridge, Pfizer Ltd., UK, Steering Committee Advisor.

At the Washington session, Moheb Nasr, PhD, Director, ONDQA, CDER, US FDA; Joseph C. Famulare, Deputy Director of Office of Compliance, CDER, US FDA; and Yatrinda Joshi, PhD, Vice President of Technical Research and Development for Novartis gave keynote sessions that addressed the 21st century perspective on the product quality lifecycle.

PQLI Steering Committee (SC) members and Subject Matter Experts (SMEs) have worked together to develop the initiative for the industry, including:  


  • Russ Somma, PhD, SommaTech, LLC (Project Team Chairman, SC)
  • Robert Baum, PhD, Executive Director, Pfizer, Inc. (PhRMA Advisor, SC)
  • John Berridge, PhD, Senior Regulatory Consultant, Pfizer, Inc. (EFPIA Advisor, SC)
  • Bruce Davis, Global Capital Director, AstraZeneca (Technical Team Leader, SME)
  • Paul D’Eramo, Executive Director Johnson & Johnson (SC)
  • Charles P. Hoiberg, PhD, Executive Director, Pfizer, Inc. (SC)
  • George Millili, PhD, Senior Director of Tech Development, Ortho McNeil GPSG (Project Team Co-Chairman, SME)
  • Joseph X. Phillips, International Regulatory Affairs Advisor, ISPE (SC)
  • Thomas W. Schultz, PhD, Director, Global Regulatory Affairs, Johnson & Johnson (Technical Team Leader, SME)
  • James Spavins, Vice President Regulatory CMC/QA, Pfizer, Inc. (Technical Team Leader, SME)


Berlin: The Next Step in Product Quality Lifecycle Implementation (PQLI)

Berlin, Germany, will be the site of the next step for PQLI. This single-day event on 19 September will serve to update attendees, build on the work begun by the PQLI initiative in Washington, and continue ISPE’s unique leadership in the facilitation of global solutions for the industry. This is an opportunity for industry representatives, particularly technical and scientific experts, to continue to develop practical solutions to implementing Q8 and Q9, and ultimately Q10 (Pharmaceutical Quality Systems), and develops fuller understanding regarding Quality by Design (QbD).

Scientists from Development, Manufacturing, Quality and Engineering will be able to engage with regulators to turn Q8, Q9, and the imminent Q10 into a cross-functional and practical reality, helping to shape the future thinking of the industry. Regulators will be present to listen to audience views and to provide their perspective.

The goal of the Berlin program is to update the attendees on the progress to date of the PQLI initiative and to discuss future plans to present and progress PQLI, and particularly to assist with design of the ISPE PQLI meetings in Copenhagen in April 2008.

Subsequent sessions will follow as concepts are developed and input received worldwide, the conclusions from which will result in technical implementation documents produced by ISPE for industry’s use in the worldwide market place.

Berlin Seminar Leaders will be John Berridge, Pfizer, UK, and Bruce Davis, AstraZeneca, UK. Others presenting will include:

  • John Berridge, Pfizer Ltd., UK
  • Bruce Davis, AstraZeneca, UK
  • Susanne Keitel, BfArM, German
  • Gert Moelgaard, NNE PharmaPlan, Denmark
  • Jacques Morenas, French Health Products Safety Agency, France
  • Chris Potter, AstraZeneca, UK
  • Tom Schultz, Johnson & Johnson, USA
  • Jim Spavins, Pfizer, USA


In addition, attendees can drill into areas of Design Space, Control Strategies and

Critical versus Non-Critical and help develop the understanding of these issues; Relate these issues to the Q9 Quality Risk Management Lifecycle concepts of State of Control, Knowledge Management, and Quality Management being proposed in Q10.


Las Vegas - Annual Meeting 5-6 November 2007

At the 2007 ISPE Annual Meeting at Caesars Palace in Las Vegas, Nevada, USA, the PQLI series will continue with the Design Qualification and Design Review, to be held 5 – 6 November.
The goal of these particular sessions is to further define areas where industry will be able to provide the technical framework for the implementation of QbD in regulatory submissions.  Regulatory agencies from around the world have been invited to this critical “next phase” PQLI event that is imperative to the success of the industry. Delegates will hear the perceptions of the regulators from the US, Europe, and Japan on the implementation of ICH Q8/9.
The process of assessing how to apply the concepts of Design Space, Critical vs. Non Critical, and Control Strategies on Biotech products will begin at Annual Meeting. Copenhagen – April 2008 The next session will be held during the ISPE Conference on Innovation, 9–11 April 2008, in Copenhagen, Denmark.

About ISPE ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals in 90 countries around the globe. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore. Visit for additional Society news and information. 

About ICH The ICH Quality guidelines on Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management) are internationally harmonised guidelines within the three ICH Regions: U.S., Europe, and Japan. Q8 and Q9 seek to integrate quality systems and risk management approaches into the existing programs and encourages adoption of modern and innovative manufacturing technology. The new guidelines help industry professionals and regulators improve efficiency and flexibility while maintaining high quality standards.