Que Es Quality Agreement

The QMS is your number one tool to reduce risk and ultimately apply your agreement. The increased visibility associated with a strong agreement is what guides you to a successful relationship. And at the end of the day, it`s much more efficient to invest in long-term supplier relationships than to have to rebuild new ones from there. By establishing a clear technical agreement, both sides know who will be responsible for what, what will avoid conflict and have clearly defined the path to escalation. During the MHRA or FDA inspection of the contract site, the inspectors` main question is how the parties share responsibility, communicate and confirm the GMP`s compliance. With a well-written technical agreement, the contract manufacturer received a prepared response to the investigator. It is therefore important to learn how to write a GMP technical agreement. You should also be sure that your agreement specifies what comes with the materials they provide, to what degree of purity, to what extent and in the delivery framework. The client must receive a full copy of the batch documentation containing:- Recording of production batches- Recording of packaging data- Analytical results for each batch of in-process production control control data- Packaging-In-Process-Control Data List (BOM)- Certificate of analysis for the final productThe GMP technical agreement is a powerful tool to maintain product quality and establish a strong working relationship between the supplier and the contract. In today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations. In such contract manufacturing cases, the EU`s GUIDELINES on Good Manufacturing Practices encourage companies to sign a technical agreement defining the roles and responsibilities of the parties concerned with regard to the production and control of medicines. A GMP technical agreement ensures compliance with current good manufacturing practices (CGMP).

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.”