In the current context of virtual enterprises and the development of outsourced medicines, it is important to properly monitor and monitor supervisory authorities. In addition, when the 2016 NACHtrags ICH/GCP E-6 (R2) is published, sponsors are required to prove that there is adequate oversight of the CROs provider, including those attributed by the cro (s) sponsor to another party. A quality agreement is the perfect tool for sketching out responsibilities and expectations. A quality agreement in the context of pharmaceutical development is an agreement negotiated and concluded between the quality services of a sponsor (pharmaceutical company) and their suppliers (CROs, etc.). It aims to define responsible responsibilities in the area of quality and to contribute to the development of safe products. Contractors inevitably have problems and quality agreements ensure that they are dealt with quickly and systematically. A quality agreement (also known as a technical agreement and, in this context, the conditions are interchangeable) is a written contract that is necessary when a company relocates an activity under the guidelines of good manufacturing practices (“GMP”). It defines the responsibilities of the various parties with respect to GMP. Quality agreements are also defined in the ICH quality documents. ICH Q7, 16.12, “There should be a written and approved contract or formal agreement between a company and its contractors that specifies the responsibilities of PMPs, including quality measures, for each party.” Expectations and Responsibilities The part of the quality agreement should be drafted in accordance with the expectations of regulators, as stated in their respective regulatory documents. In addition, a matrix of responsibility should be included in each quality agreement to clarify the responsibilities of each party. A quality agreement is developed in the first place by representatives of quality control or quality assurance of the various 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.
All of these conditions should be included in the trade agreement. If these conditions are also included in the quality agreement, they may be incompatible with the trade agreement or become incompatible with the trade agreement if one of these documents is amended at a later date. An effective quality agreement is written in a way that communicates each party`s responsibilities in a clear and concise manner, so that the reader can quickly and accurately determine to whom a particular responsibility is assigned. An ambiguous agreement is a recipe for a disaster that can result in a waste of time and money for both parties. Chapter 7 also states: “7.14: a contract should be drawn up between the contractor and the contract manager, which would define the responsibilities and communication processes for outsourced activities. The technical aspects of the contract should be developed by competent people, who would appropriately handle outsourced activities and related good manufacturing practices. All provisions relating to outsourced activities comply with applicable regulations and marketing authorization for the product concerned and are agreed upon by both parties.” The agreement must indicate which controlled and documented changes can be made by the contractor only with notification to the owner and those that must be discussed, verified and approved by the owner before they can be implemented. And in JE Q10, 2.7, “The pharmaceutical quality system, including the management responsibilities described in this section, covers monitoring and verification of outsourced activities… Responsibilities for the quality of the donor`s and contractor`s activities should be defined in a written agreement. Quality agreements help both parties conduct the overall review of the contract.