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. 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). 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. Before sampling: removal of the supragingivaven plate and drying of the respective pocket (no professional cleaning). 2. PreparationAll paper points delivered and select pockets for sampling. 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.“ 4. Conclusion Fill out the collection points and pocket depths for each tube on the contract form. 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.
3. RepeatSe each paper point with a sterile clamp in the respective tooth pocket on the Groun sulcale for 10-15 seconds. The requirement for a quality agreement is defined in the good manufacturing practice guide and in the European guidelines on good manufacturing practices.