2. PreparationPrepare the provided paper points and select dental pockets for sampling. Before sampling: removal of supragenal plaque and drying of the recessive bag (no professional dental cleaning). The ich guide provides: “There should be a written and approved contract or a formal agreement between the licensor and the verifier of the contract defining in detail the GMP responsibilities, including quality measures, of each party” In addition, the European PMP Directives provide: “The contract should clearly describe who carries out each stage of the outsourced activity, z. Knowledge management, technology transfer, supply chain, subcontracting, quality and procurement of materials, examination and release of materials, performance of production and quality controls (including process controls, sampling and analysis). It is customary for the trade agreement and the quality agreement to contain provisions relating to the same subject matter, for example. B examination fees or transfer of technology. Preferably, there should be no duplication and one of the documents should simply refer to the provisions of the other agreement instead of repeating or repeating the same provisions. In almost all cases of subcontracting of GMP activities, there will also be a commercial agreement on outsourced activities, such as for example. B a `production and supply agreement`. This trade agreement is usually developed by legal and business development officers and is not sufficiently detailed to comply with GMP principles.
If both agreements contain provisions relating to the same subject-matter, these must be carefully examined in the event that one of the agreements is subsequently amended. 4. Conclusion Fill in the sampling points and pocket depths for each tube on the contract form. 1. Contract Fill in all shapes with a pencil. the number of the contract formitted in its own documents. . It is not always necessary to seek legal advice on a quality agreement, as a lawyer is usually not able to advise on the actual details of the quality agreement. However, from a legal point of view, several issues need to be taken into consideration: a quality agreement is drawn up mainly by representatives of the quality control or quality assurance of each of the parties, and it is not always possible to seek legal advice. However, there are a number of legal issues that need to be considered when drafting or revising a quality agreement. . 3.