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. The most common risk analysis tools used in risk management activities are, for example, error modes and effects analysis (FMEA), cause-and-effect matrixes, and thermal maps. The FDA guidelines could have listed several alternative approaches to risk assessment, in which the Authority has formulated some practical experiments. For example, the agency provided feedback to the industry that calmaps should not be limited to the three high, medium and low levels, since the natural tendency is to push higher risks into the intermediate category, based on a severity aversion associated with a high valuation. Product programs combined with a device and design control component receive a quick and direct feedback from the Center for Device and Radiological Health (CDRH) when the design, process and human factors risk assessment uses this construction. 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. Iser: There are a number of important aspects to quality agreements between a pharmaceutical company and a contract manufacturer.