Selecting a partner to manufacture your pharmaceutical product can be one of the most testing and trying tasks that a product license owner can have to deal with.
This is because one is putting a critical function, related to the commercialization of your product, in the hands of someone whom you do not have direct control over ( from a line management point of view), and expecting them to perform in exactly the same way as you would, if you were manufacturing the product in your own production facility.
In terms of the licensing requirements, regulatory agencies require license holders to maintain an appropriate level of control over their product manufacture, whether this be in one of their own facilities or a third-party facility run by a CMO. However, as anyone will tell you that has dealt with this issue, saying that and executing it to a level that both meets regulatory compliance requirements and business requirements, is not always straightforward and often requires an enhanced level of oversight to assure these objectives are satisfied.
So how do we do this and how do we ensure product quality isn’t compromised?
At the heart of this process is a document called the Quality Agreement, in which both parties agree on roles and responsibilities and various deliverables to assure that the product is manufactured to agreed-upon specifications, and within prevailing cGMP regulations. These documents should be the foundation upon which the relationship is established and the details included as part of the technical body of the document. These should provide sufficient granularity to assure that the product will be consistently manufactured within the technical specifications outlined in the NDA/BLA, if we’re taking about a biological.
Within this document, there should also be provisions that outline how important decisions will be made, how the CMO will use its quality management system to interface with the clients quality management system, how technical details will be project management and how during exceptional situations, resolutions will be achieved, including an escalation process when necessary.
With these features in place then, one has started a mechanism that will ensure product quality is sustainable. That notwithstanding, there is a requirement to assure that the CMO maintains its technical competency to a degree that will always meet current GMP requirements. Client companies should arrange for a monitoring and auditing function to periodically review it’s CMO’s practices and supporting documentation, to assure that is the case.
An underscoring detail which ensures the success of all these features is an effective communication mechanism, and this can be enhanced through time and effort expended in teambuilding between the client’s and CMO’s management. Sometimes regarded as a soft function, these types of initiatives will help build effective communications that will eliminate much of the waste that frequently creeps into the process of manufacturing a product, and this will have a marked effect on both the business profitability as well as quality compliance.
However, even in the best operating relationships there will be occasions when deviations will occur and when that has to be addressed, there needs to be a joint effective and efficient deviation/ investigation procedure that involves both parties. These types of issues need to be addressed upfront and early in the relationship, so that when the need arises, there is little drama and the path to resolution is both swift and smooth.
In the course of the relationship, it is a good idea to create various checklist for the functionalities that one needs to monitor and stay on top of these. In that way, important items will not be missed. This will also reduce the wasteful time spent on deviation/ investigations and CAPA programs will be minimized.
These are just a few of the many issues that should be addressed as you select and work with a third-party CMO for the manufacture of your product and in each case the success or failure of the relationship will largely depend on the effort expended to develop an effective communication mechanism.
Without a doubt, this is the underscoring principle that lubricates everything else and determines whether or not the relationship is successful.