PharmTech: What are the mistakes made by pharmaceutical companies in the development of quality agreements? Schmitt: Although the promoter outsources certain activities, it retains full responsibility for everything the contractor does when contacting the supervisory authorities. Thus, the responsibility for the manufacture of safe products of high quality remains the responsibility of the sponsor. Therefore, it is in the proponent`s best interest to draft quality agreements that ensure that the contractor maintains high quality and compliance levels. PharmTech: How should quality agreements be organized? PharmTech: How do quality agreements improve the overall quality of pharmaceuticals? PharmTech: What are the parts of the FDA`s guidelines on quality agreements published in November 2016 that manufacturers should monitor closely? Are there similar guidelines in Europe? Schmitt: While all FDA instructions need to be followed closely, one particular aspect of manufacturers` interest relates to „approval or refusal of any changes affecting product quality and cGMP compliance” (case 5 of the guidelines). Managing changes can be a challenge when a sponsor and contractor disagree. When this happens, the FDA guide clarifies the role and responsibilities of each party, allowing both groups to better address these challenges. In Europe, written quality agreements/contracts are mandatory under existing rules, namely EudraLex Volume 4, Part 1, Chapter 7 Outsourced Activities; Part II, paragraph 16, contract manufacturers (including laboratories); and III Pharmaceutical Quality System (International Harmonization Council Q10) point 2.7. Management of outsourced activities and purchased materials. Pharmaceutical Technology asked Siegfried Schmitt, Senior Advisor at PAREXEL, about the importance of quality agreements in the sponsor-contracting relationship. Schmitt: Quality agreements should include clarity in clearly defined terminology, roles and responsibilities, as well as a well-defined scope of the agreement. These documents are intended for project managers, operational staff and quality experts.

In this context, the language of quality agreements should be appropriate for this audience and not written as a legal document. Quality agreements should also be drafted in the form of separate documents from commercial contracts, in order to maintain the flexibility to update and modify them if necessary. Schmitt: Problems are more likely to arise when both parties are not properly coordinated, which can lead to a misunderstanding about expectations. In addition, gaps may arise in some areas where the proponent and contractor have different knowledge, such as information technology.B. In order to avoid any gaps or conflicting details in an agreement, the contractor and sponsor should maintain a close relationship with clear objectives and mutual understanding of the quality agreement.