Whether or not to use a CMO can be a nerve-wracking decision for any pharmaceutical manufacturer. In their presentation, Outsourcing Dilemma: Find the Right CMO to Minimize the Risk and Maximize the Quality of Your Brand, Christa Myers, Associate/Lead Process Engineer, and Kevin Debbs, Process Specialist at CRB, specified important questions and details to look for in CMOs.
“First and foremost, this is about protecting your brand,” explained Myers, adding that it’s not a “touchy feely” decision—manufacturers must make a plan and work through the details to be able to approach upper management with reasons why a CMO is the best for the product or packaging.
Key drivers will be different for each product and process, but the right CMO should demonstrate an ability to handle the production scale and timeline. Myers added that the regulatory history must be researched, but that manufacturers shouldn’t react on the face value, as inspection frequency and the nature of findings should be taken into account.
When visiting the facility, it’s important to perform interviews and look for tells that indicate CMO quality, including:
• Clear procedures
• A well-maintained facility
• Cross-contamination control
• Engaged staff
• Age of processing equipment
Additionally, a CMO’s documentation practices should be looked into. This is a simple thing, but if it’s not being handled appropriately, it may be a bad sign. The right CMO will demonstrate confidence in its ability to provide a service, and show a commitment to your success and to having integrity. Manufacturers must take responsibility and do their homework, as Debbs concluded, “Trust, but verify.”