So why am I not describing who is responsible, system by system? This is because there is no defined model and it must be defined for your particular circumstance. Whoever does depends on who has the know-how and level of risk that you are willing to tolerate. Communication is essential. Define who, when, when, where and why. Make sure the contacts are clear to both parties and that their communication channels are open. In the world of improved electronic communication, while email is extraordinarily good, there are times when face-to-face contact is crucial. The frequency of meetings and reports is important to raise expectations. Clearly defined mechanisms prevent data overload from random people called chance persons in the other company. Sometimes things go wrong and an audit is a necessary reason. Set routine and non-routine so that it is clear when you can go. Add that you can use consultants for the exam. Put a section on what to do when you hit the heads on the edge. You hope you will need it one day, but if you do, you have put it in competition.
The FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change. The contract supplier sets appropriate storage conditions, including temperature, light and humidity for finished and bulk products. The contract manufacturer may be asked to transport the products to the contract giver or to a designated third party. The nature of the waste (for example. B solvents, toxic waste, etc.) and their specific disposal methods are also described in the GMP technical agreement, which the contractor is required to respect. An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site. If these two agreements contain provisions relating to the same purpose, they must be carefully considered if one of the agreements is amended at a later date. The ICH guide states that “there should be a written and approved contract or formal agreement between the contractor and the contractor that sets out in detail the GMP responsibilities, including quality measures, of each party.” 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. It is customary for the trade agreement and the quality agreement to contain provisions on the same subject, such as rights. B audit or technology transfer.