Managing quality at your CMOs is a critical component in developing a successful virtual supply chain and CMO relationship. A comprehensive quality strategy involves a wide range of functional participation, including: quality control, quality assurance, compliance, regulatory, technical operations, IT, planning, supply chain and manufacturing. When developing a quality and compliance strategy, one must determine the criteria and minimum standard that the CMO must meet, based on their entire site performance. Performance points of interest are:
- Corporate QA Systems
- Specific compliance history at the plant
- Comprehensive on-site audit
- Past Track Record = Future Performance
While your CMO relationship begins before the contract negotiations, the negotiations process is a key event in defining your continued relationship. Try to use your contract template as the base agreement to avoid changes to language. Clearly define who is responsible for what. Do not underestimate the time it takes to develop the quality agreement; simple agreements can take up to two months, while more complex agreements can take three to five months.
Additionally, become familiar with the organizational structure of the CMO and site personnel. A few questions to ask:
- Who is the top quality person at the site, and do they report into the plant manager or to HQ QA?
- Was there a review of the quality systems and training records?
- Who is responsible for product release?
- What are the change control procedures and SOP’s
- Are the systems validated?
Quality and master agreements may set the rules, but the goal should be to build a strong relationship with your CMO and rarely refer to the contract.
To learn more about managing quality at your CMO and performance monitoring with quality KPIs, please see our recent conference presentation.