Article | February 24, 2016

Understanding Quality Agreements Between You And Your Contract Manufacturing Organization (CMO)

Source: Ropack Pharma Solutions
Understanding Quality Agreements Between You And Your Contract Manufacturing Organization (CMO)

By Bryan Sasbon

In the broadest sense, the purpose of a quality agreement is to clearly define, establish and delineate the responsibilities of the respective QA departments from the CMO and its customer, in order to clearly communicate the responsibilities of each party, with the ultimate goal of assuring patient safety and regulatory compliance. An added benefit of implementing a clear, concise quality agreement is that it creates a more effective and efficient working relationship between CMO and customer.