Us Fda Quality Agreement Guidance

To learn how to optimize the coordination of quality agreements and other order manufacturing functions with digital tools, read the trend letter „3 Ways Contract Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration.“ Therefore, the FDA recommends that owners use a quality system model – an agreement between the parties involved in drug manufacturing, which defines and defines each party`s manufacturing activities in terms of how each party respects the CGMP – as a tool to represent manufacturing activities and support compliance with the rules. „We have made it clear that the guidelines are limited to commercial manufacturing,“ the federal registry states. „While the principles formulated may be useful in addressing quality agreements for other types of activities such as clinical research, development or distribution, these are not within the scope of this particular document.“ One of the unintended consequences of limiting the scope of the guidelines is that it allows CPPs to use them as a pretext to limit the sharing of quality responsibility to the commercial agenda. This certainly facilitates the work of the CDMO, as they have to juggle the differences between each client`s QMS. At a time when accelerated clinical plans are the norm rather than the exception, the need to maintain a practical distribution of quality responsibility during development is critical to a drug sponsor/owner`s ability to deliver a robust CMC and clinical program. This section should have been at the heart of the guidelines, but it has only two paragraphs. One of the main challenges in using a CMO is to define how the quality units of the two organizations collaborate and interact with each other. While it is true that the pharmaceutical sponsor cannot delegate its responsibility for cGMP compliance, the complexity associated with the orientation of a drug sponsor`s (QMS) quality management system to a CMO is palpable. For example, person-in-the-Plant (PIP) is a relationship point where friction can occur between an OCM and a sponsor. The rights and rights of notification, frequency, access and communication are elements that should be clearly defined in a quality agreement. A CMO has multiple clients, and each PIP requires hosting and management, which adds an additional level of organizational management to the CMO`s operation. On the other hand, the new guide gives a general overview of the areas to be included in a quality agreement. It contains sections related to manufacturing activities: Companies should be aware that the FDA intends to verify quality agreements when inspecting facilities, which is why the FDA (and we recommend) separating quality agreements from other contracts between owners and contract agencies.