By virtue of the PCMO governance, there is a steering committee made up of PDA Advisory Board members and as well as a number of task forces. As part of the PCMO governance process, each topic is prioritized to maximize the value of the expected deliverables to pharmaceutical manufacturers of investigational medicinal products (IMPs) and commercial products.
Generally on PCMO project teams, an effort is made to incorporate membership from small, local to large, global pharmaceutical and biotechnology companies, technology enablers, and, in some cases, regulators from the US and Europe. There is an understanding among participants that PDA is working toward the common objective of delivering output that embodies the best experiences of our members and, in so doing, creating consensus-based approaches that are not only grounded on ICH principles, but also are pragmatic and scalable such that they can be implemented by any size of company.
The PCMO portfolio of projects follows the product life-cycle concept and has the following broad strategic intent:
Accordingly, PCMO projects have been grouped into four broad categories: life-cycle approach, quality systems, process management, and quality risk management. These categories are also consistent with ICH guidelines and with the focus of the majority of PDA technical reports and ongoing projects. There are currently 19 PCMO projects in progress (see Table I). Additional projects will be added as necessary to satisfy the needs of the industry as recognized by PDA membership and approved by its Advisory Boards.