The recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance document (here) states that the FDA considers that the owner’s (those who engage the services of the contract facilities) Quality Unit responsibility includes approving or rejecting the contract facility’s product or service (be it for testing, processing, packing or holding). In addition, as part of a comprehensive quality systems model, the owner should utilize a written Quality Agreement whenever engaging the services of a contract facility so the respective cGMP related roles/responsibilities for the services to be provided are clear. The Quality Agreement should also include any quality specifications and define the communication mechanisms between owner and contract facility. The FDA considers the Quality Agreement to be key in facilitating compliance with cGMP to those matters relating to 21 CFR 211.22 which states that quality unit activities and procedures should be in writing.

The newly issued Guidance document defines the elements of a Quality Agreement: purpose/scope; definitions; resolution of disagreements; manufacturing activities and document lifecycle.  The bulk of the Quality Agreement will specify the roles and responsibilities for the manufacturing activities (the owner outsourced services) which depending upon the scope of the contract may include contract testing (laboratory controls). It is recommended that the Quality Agreement for contract testing references the procedures/processes by which all test results conducted by the contract facility are communicated to the owner for evaluation. The agreement should also cover the mechanism for the transfer of analytical test procedures between the owner and contract facility. It is paramount that the Quality Agreement defines the procedures for the routine owner audit of the contract facility laboratory controls to provide assurance that the laboratory operates in a controlled state in accordance with cGMP. Such auditing should include confirmation by the owner that the contract facility has a Data Integrity governance system. There should also be clear delineation of responsibility within the Quality Agreement for investigating deviations, discrepancies, OOS/OOT results between owner and contract facility.

The FDA Quality Agreements Guidance document builds upon ICH Q10 Pharmaceutical Quality Systems which states that the owner is ultimately responsible for ensuring that “processes are in place to assure the control of outsourced activities and the quality of purchased material”. The recommendation is that quality risk management is employed by the owner when assessing the suitability and competence of potential contractors before outsourcing via audits (or other qualification criteria) and regularly assessing the performance of “approved” contract facilities.

For further information relating to Quality Agreements, please contact Paul Mason, Ph.D. at or James Davidson, Ph.D. at