Now that drug manufacturers have grown accustomed to the risk- and science-based theories espoused in ICH guidelines Q8, Q9, and Q10, they must get down to more practical matters: How do we implement? For this, responsibility falls upon the industry’s professional organizations and consortia, who must distill and document best practices in areas such as Quality Risk Management and Quality Systems so that manufacturers can truly put them to use.
In 2007, ISPE launched its Product Quality Lifecycle Implementation (PQLI) initiative, aimed at supporting ICH concepts from a regulatory submissions point of view. PIC/S, the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, is a well-established collaboration of inspectorates that has grown to develop harmonized GMP standards and inspection methods, while this year has seen the genesis of Rx-360, an organization whose mission is to apply ICH principles to “enhancing product quality and authenticity throughout the supply chain.”
Now, PDA is readying its own contribution, the Paradigm Change in Manufacturing Operations, or PCMO, initiative. From PDA’s perspective, there is still an unmet need in terms of how to implement ICH guidelines, says Rich Levy, PDA’s senior VP of scientific and regulatory affairs. It has drafted a dossier around four key themes: Life Cycle Approach, Quality Systems, Process Management, and Quality Risk Management. (Note: The dossier and other related materials are available at www.pda.org/pcmo.)
PCMO draws from efforts already underway at PDA. Many of its technical reports and training sessions inhabit ICH territory, while others are in the process of being updated. Others still will be drafted from scratch. “We now have a plan of attack,” Levy says. “We’re integrating existing task forces and future tasks forces, and we’re doing it around the dossier.”
Avoiding Overlap
To be clear, this is no me-too effort, Levy says. “People might say, ‘PDA is finally getting into the swing of things,’” he says. “But we’ve been very clear that we are not going to duplicate other efforts.”
Levy is referring to PQLI, primarily. PCMO, as its name implies, will address manufacturing and inspections, Levy says, whereas PQLI is centered around regulatory submissions among the product life cycle. PDA has traditionally had more of a commercial manufacturing focus, to ISPE’s emphasis on development and tech transfer, he notes.
PDA has roughly a 20 percent overlap in its membership with ISPE—“I was an ISPE member before I was with PDA,” Levy says—so each organization will be keenly aware of the other’s efforts. They have a history of collaborative projects, such as a recent one on single-use systems, and Levy expects more. “We’re trying to get all these questions of overlap answered early on,” he says. FDA has also made it clear that it does not have the resources to support competing initiatives, Levy adds.
PCMO is in the process of refining its dossier and prioritizing which aspects deserve immediate attention. It aims to have its first deliverables—draft best practices documents, training, etc.—late this year or early in 2010, Levy says, but that will be just the start. “We see this as maybe a three-year project,” he says, “and when that time comes we’ll see where we are and what still needs to get done.”
