Stand Alone Agreement Deutsch

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. A trade agreement and the related quality agreement are not stand-alone documents, because the activities to which they relate are the same – they concern only different elements of these activities. For example, it is important to understand the relationship between the quality agreement and the trade agreement. Both documents outline the parties` responsibilities with respect to the same overall activity, for example, the activity. B of product manufacturing or product review. Sometimes a quality representative or legal counsel suggests that each document be prepared in such a way that it is alone and can be read and interpreted without reference to a second document. While this generally applies to a legal document, it is not the best approach in these circumstances. 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. 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. In addition, the European MMIB guidelines state that “the contract should clearly describe who carries out each stage of the outsourced activity.” B for example, knowledge management, technology transfer, supply chain, outsourcing, quality and supply, material control and release, production and quality controls (including ongoing controls, sampling and analysis).

All of these conditions should be included in the trade agreement.



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