Il documento presented the responsibility of the part coinvolte nel contratto, elenca i documenti ICH di maggiore importanza per le GMP (Q7, Q9 e Q10), spiega come documentare le attivit` GMP all`interno dell`agreement e glii che deve contenere, oltre ad alcuni esempi pratici. 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. 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. Nel documento the Authority raccomanda che i quality agreement contengano almeno le seguenti sezioni: A quality agreement is primarily drawn up by representatives of quality control or quality assurance of the different parties, and it is not always possible to seek legal advice. However, there are a number of legal issues that need to be known when developing or reviewing a quality agreement. Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP. A quality agreement should indicate which party will determine the specifications of the components and which party will define procedures for reviewing, qualifying and tracking component suppliers.
It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. Si é avuta una lunga discussione sull`uso dei termini owner e contract facility. In alcuni commenti ricevuti, si chiede di utilizzare i termini contract giver e contract acceptor, ma FDA afferma che questi vocaboli non sono in linea con lo scopo di mostrare come la parti possano lavorare insieme per definire, stabile e documentare gli agreement per definire le attivit