One of the common challenges to the CMO selection process is that is often a stand alone exercise. The CMOs are selected and set up at the pre-manufacture stage and then remain in place. For this reason personnel do not build up experience in how to evaluate CMOs. There are multiple factors to consider when evaluating a CMO and it takes experience and a developed skill set to select the optimum candidate. Some of the critical factors to evaluate are as follows.
Quality and Compliance
Your CMO needs to meet the quality and compliance standards for your markets. Their quality is your reputation.
Technical Expertise and Reputation
Pharmaceutical manufacturing operations covers a broad range of activities. Your CMO has to meet the demands of your product. This is especially true of complex products such as biologics or respiratory. Today many organisations are massive they may have an excellent reputation generally but what about in the specific area of your interest?
Communication and collaboration
This is absolutely key. Things will go wrong, this is one of the few guarantees you have in any pharmaceutical production. A good CMO is a partner that will work with you to find solutions and adapt to the unforeseen. Problems addressed earlier are more manageable if you are informed early.
Capacity
Nearly all CMOs will agree to accept your money but do they have the time to actually do the work. If a CMO has no free capacity how likely is it your product gets bumped off the schedule for a more important client. If you need an emergency unexpected rework can they provide this?
Cost-efficiency
Prices should be transparent and also cover contingency. The lowest upfront cost is not necessarily the best value. If you save 5% on your product testing bill but lose a major contract due to testing delays is that good value?
These are some of the many factors to consider. As mentioned earlier the process of finding the best CMO for your organisation is a skill honed through experience. Most organisations set up new CMOs very rarely so this experience can be hard to find internally. At MIAS one of our core activities is the evaluating the needs of our clients and matching them to the correct CMO. We are routinely engaged to either find the best CMO to meet your business needs, or if you already have a CMO in mind fully evaluate them. Our team Qualified Persons and QA specialists are experienced across all pharmaceutical product types and our clients big and small are spread around the world. If you need help finding, setting up, or ongoing management of a CMO MIAS can assist you.
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