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. 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.” 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. 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. Are your technical agreements on GDP compatible with the agreements that are in place under trade agreements? If you don`t, you`re in serious danger of arguing. The written contract mentioned in the clause is generally referred to as a technical or quality contract and describes the responsibilities of both parties, i.e. the contractor and the contractor. The client should indicate his requirements, as the structure of a technical agreement varies according to these requirements. Some contract manufacturers keep their own model for a standard technical agreement, but you need to make sure it meets your criteria before signing the document. A standard technical arrangement should include the following: it is important to ensure that the two agreements are referred to each other and to ensure that anomalies between the two documents are avoided, as this could be a challenge in the event of a dispute.
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. 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. The technical agreement does not apply to the terms and conditions between the two legal entities.