The big question is: why would the Agency publish a guide that only deals with commercial manufacturing? The role of the control manufacturer has grown over the past decade, from API design to pharmacovigilance to clinical logistics. Commercial manufacturing is the relationship with which the biopharma industry has the most practical experience, and the content and application of the quality agreement is well understood between the owners and the CMOs. It is strange that the FDA has decided to limit the scope of the guidelines to the commercial side when the main challenges facing the industry are commercial production. The quality agreement provides a way and structure to define the expectations of the parties, identify deviations from those expectations, and define an escalation process to address/mitigate those gaps. The key to the successful negotiation of the quality agreement is the clear communication of expectations between the parties and the emphasis that each party has a sense of ownership of the study by a commonly established and agreed language. Two common objections raised by vendors during metrics negotiations were, as sponsors acknowledged, that the resources needed to collect and manage metrics could discourage the vendor`s actual performance for their study-related tasks and how certain metrics can be influenced by forces beyond the vendor`s control. First, when negotiating metrics, we have made an effort to continuously evaluate the metrics typically collected by the clinical service provider and, therefore, we have only tracked additional metrics if we deem it absolutely necessary. By looking at metrics that can be influenced by forces that are not directly controlled by a supplier, we have made sure to allow „carve outs” that include „force majeure”, natural disasters and unforeseen changes in the regulatory authority. Beyond these common objections, both sides recognized that the purpose of quality agreement measures is to determine whether there is in all our studies a model that can be learned and applied from ongoing and new studies in order to prevent the recurrence of joint complaints from sponsors/suppliers. On the other hand, the new guidelines give a general overview of the areas to be included in a quality agreement. It contains sections on the following, since they relate to manufacturing activities: cooperation is essential for any successful business partnership, so it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization.
Processes such as corrective and preventive measures (CAPA) and deviation management have the potential to create disagreements, so responsibilities related to studies and other processes related to the management of the quality event should be clearly defined in the agreement. The guidelines also stress that quality agreements should be clear as regards the release of products. In the eyes of the FDA, any activity that is not documented also cannot have taken place. . . .