Richard Levy
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In June 2008, the Parenteral Drug Association (PDA) Board of Directors approved the development of a new initiative called
the Paradigm Change in Manufacturing Operations, or PCMOSM for short. The goal of the PCMO program of activities is to provide an overarching framework for topics which will become
the subject matter of future PDA technical reports and other documents and training events.
Background
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.
Table I: PCMO project portfolio.
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The steering committee has developed a portfolio of current deliverables (see Table I) to facilitate the implementation of
the guidelines from the International Conference on Harmonization (ICH) guidelines Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
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.
PCMO projects
The PCMO portfolio of projects follows the product life-cycle concept and has the following broad strategic intent:
- Enable an innovative environment for continual improvement of products and systems
- Integrate science and technology into manufacturing practice
- Enhance manufacturing process robustness, risk-based decision-making and knowledge management
- Foster communication among industry and regulatory authorities.
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.
