Process knowledge and management commitment
Manufacturing personnel should work closely with quality personnel within the client and CMO companies to share knowledge
of the process, to understand what works well and what needs improvement, and to proactively identify potential problems before
they occur. The CMO and client should jointly manage product and process knowledge throughout the product lifecycle. Knowledge
should be documented and shared and should include public queries, where applicable, and internal information. Knowledge should
be communicated to stakeholders and should include product and process development, tech transfer, process validation, manufacturing
experience, improvements, and change management.
Senior leadership at both the client and the CMO needs to be engaged and supportive of a quality culture; and quality leadership
needs to be responsible to educate them. Senior leadership needs to see the passion of their quality leadership in assuring
this culture and they need to be educated on the cost of nonquality. They need to see examples of the effect of consent decrees
and warning letters on the finances and reputations of companies who do not adopt a quality culture.
To best manage a product portfolio, consider taking a lifecycle approach for each product. A product is discovered, developed,
made, sold, improved, then, sometimes, is discontinued or removed from the market. Each stage is different and requires an
understanding of the needs of each stage. GMPs of a Phase I clinical product are different than GMPs of a commercial product;
this should be clear and should be in writing to provide direction. Many people struggle, debate, and argue the same points
over and over again without coming to any conclusions, other than "Quality is unreasonable" or "Manufacturing doesn't understand
GMPs." The discussion and debate should happen once, with the right level of management, with the right guidance, resources,
logic, and common sense over a significant period of time. A document outlining the company's position should state the firm's
In every significant, commercial CMO/client relationship, a one-page scorecard should be developed to measure performance
(see Figure 1). This scorecard should include 10 key performance indicators to determine the health of the relationship. It should focus
on areas of opportunity or pain points; define formulae and process/people to measure them; and define timing to collate prior
to business review meetings. Effective KPIs are SMART: specific, measurable, achievable, relevant and time-bound.
Figure 1: Client/CMO scorecard. (ALL FIGURES ARE COURTESTY OF THE AUTHOR)
Do not try to measure everything. Focus on those areas where pain is felt. Improvements in these areas will feel satisfying.
If there is no pain, then measure important, not just urgent areas.