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

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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

CLIENT/CMO RELATIONSHIP MANAGEMENT

Tools can be used to manage the CMO/client relationship including contracts (e.g., supply agreement, technical quality agreement); audits, due diligence (prior to using them) and routine (e.g., annual) visits; regularly scheduled operational meetings (frequency dependent on volume of lots made); start/sustain strategic business review meetings (e.g., quarterly), leveraging a scorecard with key performance indicators (KPIs); joint investigations; and joint material review boards. Trust-based relationships are crucial for success. Intangible relationship skills and attributes allow for an honest, trust-filled relationship. These are attributes that should be encouraged.

Important points should be documented on a timely basis to assure they are captured accurately. Major decisions and agreements between companies should be captured in meeting minutes. People tend to say a lot when unchallenged, but, when they write it down, there is an additional level of scrutiny to assure accuracy. Verbal discussions are like fish stories; after being passed on, they morph into something that was never said.

CMO oversight

A client cannot be afraid of being honest in their thinking. Concerns should be brought up early with the CMO. Prioritize issues so the CMO understands the client's priorities. An agenda should be written in advance, with planned attendees listed and timing, also documenting priorities or discussing highest priority items first. At the end of the meeting, recap salient points, actions, responsible people, and target dates. After the meeting, generate minutes, with all major decisions and salient points verified. Endorse minutes for posterity and keep on file.

During a routine inspection, an FDA investigator from the Center for Biologics Evaluation and Research (CBER) said, "The quality unit in a company is like an internal FDA department; if doing its job, FDA can feel confident with the firm's cGMP compliance." Dig deep to uncover problems and put a plan in place to fix them after prioritizing them appropriately.

Foreign suppliers

A major concern these days in the choice of a CMO is location. More than 70% of APIs are made outside the US. Many are made in countries with less stringent regulatory requirements than the US.

Additional scrutiny, diligence, assessment, and mitigation of risks are needed when choosing suppliers in foreign countries. The risk of poor compliance in certain foreign countries is much higher, however. FDA now has an office in Shanghai, China and is planning to increase its foreign inspection cadre to improve the safety of foreign drugs imported to the US. It is, however, the client's responsibility to also assure compliance.


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