Mhra Technical Agreement Template

Technical agreements on GDP are usually written by an expert who specializes in gdp principles, and trade agreements are written by the company`s legal department. 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 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 typical technical agreement should include the following: the client sets the 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 clauses contained in a technical agreement on THE PRINCIPES OF GDP depend on the outsourcing of the activity. For example, a technical agreement on GDP between a WDA (H) holder and a contract warehouse may include the following details: Make sure that your technical agreement contains all the CGMP rules applicable to the manufacture of a particular product. – active and excipient-dependent raw materials must be obtained in accordance with „guidelines to minimize the risk of transmission.” The contractor cannot make any changes to the process, raw materials or formulation without the prior written consent of the contracting entity and the supervisory authorities. – the holder cannot delegate his obligations to third parties without the consent of the adjudicator power. – Record discrepancies between pre-defined procedures or desired results.- It is up to the contractor to keep batch records for a defined period after the demage.