Choosing a CMO – 

Selection of a Contract Manufacturing Organization (CMO) to manufacturing your drug substance, drug product or clinical packaged product can be a challenging task.  A sponsor’s criteria typically include the CMO’s technical knowledge, scale of manufacturing equipment, size/number and ISO classification of manufacturing suites, analytical capabilities/equipment, facility location (for ease of communication and travel to/from), GMP compliance, costs, and their ability to meet your timelines. 

Equally important, but often overlooked, are Professional Relationships – 

• Do you think you can develop relationships with key employees?
• Will production management call or text you in the middle of the night and on weekends if a serious production deviation occurs?
• Will the head of Quality Control promptly call, text, or email you when release or stability results look odd but are not out of specification?
• Are key employees open to impromptu calls from you to discuss ideas for optimizing the manufacturing process or sourcing of alternate suppliers of raw materials?
• Will the CMO’s project manager immediately contact you upon discovery of a delay in shipment of a raw material, packaging component, or new equipment purchase that has the potential to affect the start date of your production?
• Will receiving personnel promptly notify you when your active pharmaceutical ingredient arrives at the dosage form manufacturer in a crushed container?

Although many of the above items are often included in CMO / Sponsor Quality Agreements, this does not necessarily mean that these needs will be met.  It comes down to developing professional relationships with the CMO’s stakeholders so that you are always in the loop on issues that can affect your timelines and the quality of your product.

If it appears unlikely that these important relationships can be established and maintained its best to look for different CMO.

Discover How Eastlake Quality Consulting Can Qualify Your GMP suppliers.