The responsibility for manufacturing safe, high-quality products therefore remains with the sponsor. Therefore, the promoter has every interest in drafting quality agreements that ensure that the contractor maintains a high level of quality and compliance. Schmitt: Quality agreements should include clarity in terminology, clearly defined roles and responsibilities, and a well-defined scope of the agreement. These documents are intended for project managers, company employees and quality experts. As regards these users, the language of quality agreements should be appropriate for this target group and not be written as a legal document. Quality agreements should also be drafted as separate documents from trade agreements, in order to maintain the necessary flexibility to update and amend them if necessary. Schmitt: Rather, problems arise if the two parties are not properly coordinated, which can lead to a misunderstanding about expectations. Change management can be a challenge if a sponsor and contract acceptor disagree. In this case, the FDA`s guidance clarifies the role and responsibilities of each party, which allows both groups to better address these challenges.
In Europe, quality written agreements/contracts are required under existing rules, namely EudraLex Volume 4, Part I, Chapter 7, Outsourced Activities; Part II, paragraph 16, manufacturer of controls (including laboratories); and Part III Pharmaceutical Quality System (International Council for Harmonization Q10) paragraph 2.7. Management of outsourced activities and purchased materials. PharmTech: How to design quality agreements? New – Parametric output (commissioning deadline: December 26, 2018) For more information to view, click here.