The ICH Guide states: “There should be a written and approved contract or formal agreement between the contractor and the auditor of the contract detailing each party`s GMP responsibilities, including quality measures” A section of the agreement should address specific considerations relating to individual products. It should also determine how owners share knowledge, such as product and process development information, with contract facilities to ensure that manufacturing is GMP-aligned. The guide asks owners to review and approve most changes before implementing them. However, in some circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement should define how all these changes are made and managed.