Today, more pharmaceutical companies are turning to outsourcing their products as a strategic part of their business model. There are a number of drivers for this shift to soliciting the services of a Contract Manufacturing Organization (CMO) which could include capacity issues, lack of technical expertise in-house, and lack of appropriate product equipment, facilities and utilities. For many companies, choosing the right CMO for their project is the first critical step to determining the probability of success. With so much at stake at this point in the process, how should you systematically go about identifying this critical strategic partner while maintaining and/or increasing your internal Knowledge Management process? The balance of this article will cover an overview of the first steps required to successfully select the right CMO for your project following a methodology that our organization has successfully employed. The remaining steps will be covered in a future article.
You cannot start to look for a solution without a common understanding of the problem. What are we trying to make and where do we want to make it? Checklists and common storage locations (file cabinets or database) are two of the best tools and techniques to employ at this stage of the process. The goal is to assemble as much of the known information as is available from the sending site. Trust us when we say that every scrap of paper has value. This is the jumping off point for the implementation of the knowledge management process.
The process starts by cataloguing known information. At the completion of this phase of the project, this would be a good opportunity to start the process of centralizing the collected information into the Knowledge Management Based system whether technology based or a softer system is in place. If a Knowledge Based system is not in place, thought should be given to implementing/creating a system for this purpose. The information collected at this point of the project will be critical to the identification and selection of the right CMO for your project.
Developing the list
At this point we have now assembled all data of the product attributes, required equipment for the manufacturing and packaging processes, any special environmental conditions, testing requirements including instrumentation, any special storage conditions for the Raw Materials, Finished Product and specific shipping requirements. It is now time to identify five to six potential CMO partners. Several options are available for the search process including internet search, industry colleague references, trade magazine advertisements or a CMO search tool.
These steps are only the beginning of the selection process, and will help lay the foundation for a smooth progression. We will be discussing the remaining process steps with information on screening and evaluating candidates, and negotiating the final contracts in a future blog post.