If a separate control laboratory is involved, all relevant roles and responsibilities must be defined. The quality agreement should explicitly specify what data is shared and how it is disseminated. 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 the manufacturing activities of each of the parties with respect to CGMP compliance. The agreement should clearly indicate whether the owner or the contracting entity (or both) performs certain CGMP activities. (1) The guide encourages owners to review and approve most changes before they are implemented. However, in certain circumstances, there are modifications that contractors can implement without notifying the owner. A quality agreement should indicate how all these changes are made and managed. The FDA`s current position on quality agreements is set out in the « Contract Manufacturing Arrangements for Drugs: Quality Agreements » guidelines published in 2016. The guidelines explicitly state that manufacturing activities are the most important element of a quality agreement. It highlights the seven most critical areas that should be the subject of a quality agreement and their specific implications in terms of quality and change control. I recommend to Guidance for Industry Q10 Pharmaceutical Quality System that the owner, as part of a pharmaceutical quality system, is ultimately responsible for ensuring that « processes are in place to ensure the control of outsourced activities and the quality of materials purchased. » It recalls that these processes should include risk quality management and include critical activities such as: the new draft guidelines describe the obligations of the parties, the delimitation of responsibilities and how to ensure the quality, safety and efficacy of medicinal products in the manufacture of orders. It applies to the commercial manufacture of: – pharmaceutical substances (APIs or pharmaceutical substances or their intermediate products), – finished medicinal products, – combination products and – biological medicinal products A quality agreement is a comprehensive document which describes both specific quality parameters for a project and the party responsible for carrying out those parameters.

The level of detail of a quality agreement varies depending on the development phase of the project. First of all, it is important to keep in mind that the new guidelines reflect the FDA`s current thinking on production business relationships, not research and development, and that the following categories apply: drugs for human use, veterinary drugs, certain combination products, biologics and biotechnology products, finished products, APIs, pharmaceutical substances, process materials and pharmaceutical components of combined drugs / device products. The guidelines do not cover the following product types: Type A drugs and medicated foods, medical devices, food supplements or human cells, tissues or cellular or tissue products regulated under Section 300 of the Public Health Service Act and 21 CFR Part 1271. The agreement should not contain certain points such as general terms and conditions of sale, price and escalator clauses, forecasts, delivery conditions, confidentiality obligations and limitations of liability. These positions are included in the delivery contract, which is separate proof. The quality agreement may be included by reference in the delivery agreement. If both documents are established as a single document, the whitelist may contain people who have no reason or no time to check for issues that have nothing to do with their area of expertise. One element of the CMO`s commitment, which has been hotly debated in the sector, is the quality agreement which, in the new guidelines, « defines and establishes a comprehensive written agreement between the parties involved in the manufacture of medicines, which defines and defines the manufacturing activities of each party with regard to compliance with CGMP ».

Given that CMOs assume a much larger share of the responsibility for development – which develop in CDMs – many questions have been raised about the content and timing of quality agreements. . . .