Initiative launched to tackle ICH

The new initiative, Product Quality Lifecycle Implementation (PQLI) focuses directly on solving the challenges associated with Q8 (pharmaceutical development) and Q9 (quality risk management) of the ICH guidelines. To do this the ISPE is working with regulators in the US, Europe and Asia-Pacific in a variety of sessions to define areas where industry will be able to provide the technical framework for the implementation of quality by design (QbD) in regulatory submissions. The first PQLI session was held in Washington last month and 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,"​ ISPE project team chairman and steering committee member Russ Somma said. "The energy at the Washington inaugural session confirmed just how important this initiative is to the industry." ​ A working group will continue to monitor the progress. ISPE steering committee advisor John Berridge said in a statement: "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." ​ The second session is in Berlin, Germany, in September. Additional sessions will be held in Las Vegas, and Copenhagen, Denmark. Conclusions from the sessions will result in technical implementation documents produced by ISPE for industry's use in the worldwide market place. The ICH guidelines on Q8 and Q9 are internationally harmonized guidelines within the three ICH regions of the US, 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. Last month, ISPE published its latest guide which was a revised edition of its manual providing industry guidance on facilities and production of active pharmaceutical ingredients.