Imagine having a drug safety issue on site that requires a recall, but your company does not have a quality agreement with the manufacture of the product. How would your business handle the situation? What would you do if the contract manufacturer did not agree to a recall? An effective quality agreement solves these concerns and challenges. 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). Quality agreements are not only good business practices, but also regulatory requirements. ICH Industry Guide Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure that contract sites meet CGMP for certain operations. Written agreements should also set out considerations relating to subcontracting. They should describe how changes to processes, equipment, methods and specifications are managed and allow the owner to verify the owner`s compliance with CGMP. 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. According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines each party`s production activities with respect to CGMP compliance. The agreement should make it clear whether the owner or contracting body (or both) is engaged in certain CGMP activities. (1) Quality agreements assist both parties in conducting the overall review of the contract.