There was a long discussion about the use of the terms of the owner and the contracting body. In some of the comments received, we ask for the terms of use of contractors and contract operators, but the FDA explains that these words are not related to how the parties can work together to define, stabilize and document agreements to define production activities and ensure GMP compliance. “Our review clarifies the purpose and applicability of the directive and the main terms to be used. In terms of purpose and applicability, we have made it clear that the guide is limited to commercial production activities. While the principles outlined may be useful in addressing quality agreements for other types of activities such as clinical research, development or distribution, they go beyond the scope of this document. Owners and contract organizations can rely on quality management principles for the implementation of the contract by defining, establishing and documenting activities to ensure compliance with PMCs and product quality, safety and effectiveness. The FDA recommends that quality agreements have at least in themselves: “From the perspective of the CGMP, the most important elements of a quality agreement are the sections that define the responsibilities of the parties and the debate on controlling change. The FDA has definitively approved the new guidelines for quality agreements for contract manufacturers. .

There is particular interest on the part of the FDA for the definition: Frequent short expressions: 1-400, 401-800, 801-1200, Other results: 383. Exactly: 2. Reaction time: 293 ms. The long wait was caused by the FDA`s desire to better compare and clarify the differences between the 2013 draft and the final version. “The guide describes the FDA`s current thinking regarding the definition, implementation and documentation of the contract parties` production activities, in accordance with the requirements of the PMPC.