September 20, 2021

A quality agreement is a comprehensive document that defines both specific quality parameters for a project and the party responsible for executing those parameters. The level of detail of a quality agreement varies depending on the development phase of the project. It is important that these aspects, as well as other recommendations contained in the current guidelines, are taken into account when developing and implementing agreements with contractual entities. Quality agreements help both parties in the overall contract analysis process. They define, establish and document the roles and responsibilities of all parties involved in the process. Quality agreements allow each party to define its expectations and rules for projects and to ensure that the quality characteristics of both parties are consistent and that each party receives effective quality services and products. A sufficiently detailed quality agreement can help to avoid assumptions leading to conformity errors. While a quality agreement defines the specific quality parameters of a project and which parties are responsible for its execution, the degree of detail varies depending on the development phase of the project. At least a quality agreement should describe each party`s obligations and responsibilities in the following building blocks: Iser: In accordance with the FDA`s current guidelines on quality agreements, “quality agreements can be verified during inspections,” and current rules in the United States, Europe, and other regions contain expectations for outsourcing manufacturing activities. Therefore, undertakings that are inspected by a regulatory authority should have all applicable quality agreements in place so that they can be made available to the inspector/inspector on request.

PTE: How can pharmaceutical companies and subcontractors enter into quality agreements that clarify the responsibilities of each company? One of the unintended consequences of limiting the scope of the Guidelines is that the CDMs can use them as a pretext to limit the distribution of quality tasks up to the trade programme. This certainly makes the CDMO`s job easier, 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 allocation of quality responsibility during development is critical to a drug sponsor/owner`s ability to ensure a robust CMC and clinical program. A quality agreement should contain at least the following sections: Deviation and capa management (corrective and preventive action) are other potential areas of contention. Deviations require the CMO and the Sponsor to understand the cause and effects of a process or excursion in the QMS. The primary responsibility for the analysis of the causes must be clearly expressed in the quality agreement, as well as when and how a drug sponsor can participate in an investigation. . . .

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