Gdp Technical Agreement Template

If you need help establishing a robust GDP technical agreement, please contact Pharma Experts. GDP technical agreements are usually written by an expert specializing in GDP principles and commercial agreements are written by the company`s legal department. By signing a technical/qualitative agreement, both parties develop a common understanding of quality. Although draft contracts may be used for this purpose, individual specificities should be duly taken into account. The contracting entity is responsible for the outsourced activities and a technical agreement ensures that the night of the contract complies with the principles of the DGP. It is important to ensure that the two agreements refer 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. Do your GDP technical agreements coincide with existing trade agreements? If this is not the case, you are exposed to a serious risk in the event of an argument. Many distribution and medicine transport services are provided by external logistics service providers, and other activities in the DGP environment are often outsourced. In this context, the question arises as to when a technical/quality agreement should be signed, what regulatory requirements apply and what aspects should be covered by such an agreement.

The technical agreement does not contain commercial conditions between the two legal persons. These should be covered by a separate commercial agreement between the contractor and the contract promoter. The clauses contained in a technical agreement on the principles of the DGP depend on the outsourced activity. For example, a GDP technical agreement between a WDA (H) holder and a contract warehouse may contain the following details: the written contract mentioned in the clause is generally referred to as a technical or qualitative agreement and describes the responsibilities of both parties, i.e. The licensor and the contractor. In addition, in accordance with Chapter 4.2 (Documentation), contracts should be readily available/accessible as part of the documentation (all written procedures, instructions, contracts, records and data, in paper or electronic form). If a wholesaler wishes to outsource activities to external companies, the requirements of the guidelines of 5 2013/C 343/01), which mention contracts in several chapters. In general, the following aspects should be taken into account: Chapter 9.2 (Transport) states that “where the carriage is carried out by a third party, the current contract should include the requirements of Chapter 7.