Managing Contract Manufacturing Organization Relationships - Successful management of the CMO/client relationship should include open communication and trust. - BioPharm International


Managing Contract Manufacturing Organization Relationships
Successful management of the CMO/client relationship should include open communication and trust.

BioPharm International Supplements
Volume 26, Issue 3, pp. s22-s26

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.

Lifecycle approach

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 minimum requirements.

Measuring performance

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.

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.

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