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.
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.
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.