Gxp Agreement

A quality agreement should indicate which party will determine the specifications of the components and which party will define procedures for reviewing, qualifying and tracking component suppliers. It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. The guidelines encourage homeowners to verify and approve most changes before being implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed. If a separate contract laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly state what data is transmitted and how it is disseminated. Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP. Cooperation is essential to any successful business partnership, which is why it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization.

Processes such as corrective and preventive measures (CAPA) and gap management can lead to dissent, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement. The guidelines also state that quality agreements should be clear with regard to product release. 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. At least, a quality agreement should reflect the obligations and responsibilities of each party in the following basic elements, which are mentioned in the guidelines: the FDA does not have specific guidelines regarding quality agreements between medical device companies and CMOs that provide them with services.