Contract Manufacturing Organizations, CMOs, have become commonplace in the life sciences industry. Entering into a CMO partnership comes with many benefits and risks. It is important for a company to do its research when selecting a CMO. Choosing the wrong CMO can lead to production issues, delays, or even the need for a recall. Having a proper selection process and supplier management system can help mitigate these risks.
Understanding the product and what is needed for that product is the first step in the selection process. Pharmaceuticals, medical devices, biologics, and digital products all have different regulatory requirements that must be met during the manufacturing process. Those regulations are set by the FDA or other relevant regulatory bodies depending on the market the product is being sold in. If the product is being sold in multiple markets then all the relevant regulations must be met. Even if the CMO is located in another country they still must be compliant with those regulations.
After understanding the needs of the product looking at what a potential CMO is capable of is the next step. Their production capacity, facilities, equipment, and equipment maintenance are all important factors for a company to consider when looking at a CMO. A CMO, while considered a supplier to the product owner, should also have a proper supplier management system in place for their supplies. Supplier management, facilities, equipment, and other factors are all regulated under the FDA CFR part 820.[1] While there may be many initial options, a company should use the selection criteria to narrow down the field to only a handful of candidates.
Once a CMO is selected they should be approved via the supplier selection process of the company. Supplier Management procedures should already be established by the company. The roles and responsibilities of the CMO should also be established. EMMA International can help assist with selecting and vetting a CMO. Additionally, our technical experts can help develop and establish a comprehensive supplier management system. From start to finish EMMA International’s full service consulting can help reach the market and stay on the market. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.
[1] The FDA Group (February 2020) A Quick Guide to FDA’s Expectations for Supplier Quality, Retrieved 11/28/2021 from https://www.thefdagroup.com/blog/a-quick-guide-to-fdas-expectations-for-supplier-quality
