This guide describes the FDA`s current thinking on the definition, implementation and documentation of the manufacturing activities of the parties involved in the manufacture of contract drugs subject to the current requirements for good manufacturing practices (CGMP). In particular, we describe how parties involved in drug manufacturing can use quality agreements to define their manufacturing activities to ensure compliance with PMCs. One element of the CMO`s commitment, which has been hotly debated in the sector, is the quality agreement that, in the new guidelines, “defines and establishes a comprehensive written agreement between the parties involved in drug manufacturing, which defines each party`s manufacturing activities based on how each party will comply with the PMC.” Given that the CMO assumes a much larger share of development responsibility – which is turning into a CDD – many questions have been raised about the content and timing of quality agreements. Indeed, the real usefulness of high-quality agreements has been the subject of debate. Let`s look at the FDA`s new guidelines in this context. In addition, the European MMIB guidelines state that “the contract should clearly describe who carries out each stage of the outsourced activity.” B for example, knowledge management, technology transfer, supply chain, outsourcing, quality and supply, material control and release, production and quality controls (including ongoing controls, sampling and analysis). A standard operating procedure should be put in place to indicate the types of creditors and services for which a quality agreement is required. At a minimum, an agreement must be reached at any time when an OCM is used, as well as with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components.

A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. A quality agreement should at least define the obligations and responsibilities of each party in the following basic elements mentioned in the guidelines: it is customary for the trade agreement and the quality agreement to contain provisions on the same subject, such as rights. B audit or technology transfer.