In today`s environment of virtual businesses and outsourced drug development, it is important to maintain and demonstrate oversight by regulators. With the publication of the ICH/GCP E-6 (R2) 2016 Addendum, proponents must also demonstrate appropriate monitoring of CROs by suppliers, including those assigned by the proponent`s cro(s) to another party. A quality agreement is the ideal tool to define responsibilities and expectations. A quality agreement in the context of pharmaceutical development is an agreement that is mutually negotiated and concluded between the quality departments of a sponsor (pharmaceutical company) and their suppliers (CRO, etc.). It is intended to define responsibilities with regard to quality tasks and to help ensure the development of safe products. Contractual partnerships inevitably have problems and quality agreements ensure that they are dealt with quickly and systematically. The communication must also define what happens in the event of a dispute that may be raised by both parties. The agreement should document the dispute settlement mechanism and, ultimately, which legal system the country will benefit from the financial generosity of both organizations when they fight it in court. Not surprisingly, I am in the camp with the great spectroscopist “Dick the Butcher”, who said: “The first thing we do, kill all the lawyers” (11). A section of the agreement should deal with specific considerations relating to individual products.
It should also determine how owners share knowledge, such as product and process development information, with contract facilities to ensure that manufacturing is GMP-aligned. Quality agreements are not only good business practices, there are also regulatory requirements for them. ICH Industry Guidelines Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contracted facilities to ensure contractors` sites are GMP compliant for certain operations. Written agreements should also remove subcontracting considerations. They should describe how changes to processes, equipment, methodologies and specifications are managed, and allow the owner to verify the compliance of their contractor`s facilities with the CMP. Quality agreements between suppliers and suppliers define the conditions relating to the quality of materials or services delivered to a production facility used in the products or in the manufacture of the products. Quality of service agreements define the conditions relating to the quality of services provided to a production facility and used in the manufacture of products. In addition, the European GMP Guidelines provide as follows: “The contract must clearly describe who carries out each stage of the outsourced activity, e.B. Knowledge management, technology transfer, supply chain, subcontracting, quality and procurement of materials, testing and release of materials, production performance and quality controls (including in-process controls, sampling and analysis). All activities under the quality agreement must be carried out in accordance with the applicable GMP regulations. .