ISCT-AABB Quality Agreement Template

In the field of Biotherapy partnerships, agreements with external entities to perform critical services have become more commonplace.  These services can include procurement, manufacturing, testing and administration of a cell/tissue product. Such relationships are defined through the use of a Service Agreement and a Quality Agreement. Service contracts typically outline the scope of work, deliverables, timelines, budgets, and business and legal liabilities. Quality Agreements identify and describe key quality and regulatory responsibilities between the client and the service provider.

The intent of a Quality Agreement is to have clearly defined expectations between parties with emphasis on each party having a sense of ownership through mutually agreed upon language and activities. At a minimum, the Quality Assurance personnel of all entities should have input into drafting the Quality Agreement, with feedback from the respective stakeholders including but not limited to: sponsor, investigator, administration site, and procurement, processing, manufacturing facility(ies).