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. A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. At a minimum, a quality agreement should define the obligations and responsibilities of each party in the following basic elements mentioned in the guidelines: when a separate contract laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly state what data is transmitted and how it is disseminated. It is important to ensure that intercompany agreements respect reality, comply with transfer pricing documentation and comply with market standards. The FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change. If you need price-compliant intercompany agreements for your controlled transactions, we have something for you… In practice, companies often neglect contractual obligations between companies. And even when intercompany agreements are concluded, they are often poorly drafted, obsolete and do not reflect the economic reality of controlled transactions.

The lack of intercompany (quality) agreements can be a risk for many reasons. These are the three main ones: with regard to the content of the intercompany agreements, we put forward three key principles: the development of an intercompany agreement is done in a multidisciplinary approach. Tax and financial experts develop transfer pricing documentation, but may not have the expertise to establish legal documents. Similarly, lawyers are generally in the dark about transfer pricing rules. It is therefore important to ensure that the right people and skills are on board. 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. 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) Transfer pricing agreements between associated companies must be formalised in intercompany agreements in order to make them legally binding, to comply with transfer pricing legislation and to ensure an appropriate line of defence against the challenges posed by tax authorities. If you don`t, your business is seriously and unnecessarily threatened.