Was Ist Ein Quality Agreement

The guide encourages owners to review and approve most changes before they are implemented. However, in certain circumstances, there are modifications that contractors can implement without notifying the owner. A quality agreement should indicate how all these changes are made and managed. Part of the agreement should address specific product-specific considerations. It should also define how owners pass on knowledge, such as product information and process development, to contracting entities to ensure that manufacturing is compatible with CGMP. By defining a clear technical agreement, both sides know who is responsible for what, thus avoiding conflicts and have defined a clear path of escalation. When inspecting the contract site by the MHRA or FDA, the main question for inspectors is how the parties share responsibility, communicate and confirm GMP compliance. With a well-written technical agreement, the subcontractor has a ready-made answer to the investigator. Therefore, it is important to learn how to create a GMP technical agreement. In today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations.

For such cases of contract manufacturing, the EU Guidelines on Good Manufacturing Practice require companies to sign a technical agreement defining the roles and responsibilities of the respective parties with regard to the manufacture and control of medicinal products. A GMP technical agreement ensures compliance with current Good Manufacturing Practices (GMP). In the eyes of the FDA, any activity that is not documented may just as well not have occurred. A quality agreement gives the contractual facility and the owner the opportunity to set expectations as to who reviews and approves quality documents. It shall describe protocols for modifying standard operating procedures (SOPs), manufacturing records, specifications, validation documentation and other essential documents related to the goods or services provided by the procuring entity. The role of both parties in creating and updating original documents or original GMP copies should be clarified. The agreement should also specify how these records are to be made available for inspection. It is beneficial to include a statement that electronic records are stored in accordance with GMP and kept in a recoverable state during the required registration windows specified in applicable regulations in accordance with FDA requirements. The FDA`s current position on quality agreements is set out in the 2016 guidelines “Contract Manufacturing Agreements for Medicines: Quality Agreements.” The guidelines explicitly state that manufacturing activities are the most important element of a quality agreement. It highlights the seven most critical areas that should be addressed in a quality agreement and their specific impact in terms of quality control and change. .

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