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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. In almost all cases of outsourcing of BMP`s activities, there will also be a trade agreement covering outsourced activities, such as a „manufacturing and procurement agreement,“ for example.B. This trade agreement is generally developed by legal and commercial development staff and does not go into detail to comply with the principles of the GMP. 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. 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). 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 contains nine cultivation tools that cover process details, materials, CPI, product specifications, stability, customers and labels. This ready-to-use model requires only a small amount of location-specific changes before you can fully accept it for your operations. All you need to do is enter your site-specific information into the marked colored fields. 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. It is preferable that there be no duplication and that one of the documents simply refers to the provisions of the other agreement instead of repeating or repeating the same provisions.