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Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.
PharmTech: Which parts of FDA’s quality agreements guidance, which was published in November 2016, should manufacturers pay close attention to? Are there similar guidelines in Europe?
Schmitt: Although the entire FDA guidance should be paid close attention to, one particular aspect of interest to manufacturers relates to ‘Approving or Rejecting Changes that Affect Product Quality and cGMP Compliance’ (Case 5 of the guidance). Change management can be challenging when a sponsor and contract acceptor disagree. When this occurs, the FDA’s guidance provides clarity around each party’s role and responsibilities which allows the two groups to better overcome these challenges. In Europe, written quality agreements/contracts are mandated within existing regulations, namely EudraLex Volume 4, Part I, Chapter 7 Outsourced Activities; Part II Paragraph 16 Contract Manufacturers (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 can quality agreements enhance the sponsor/contractor relationship?
Schmitt: While many sponsors and contractors may share a close commercial relationship, quality agreements add a compliance component. This helps to build more of a common understanding of each side’s needs, building additional trust. Possessing a written framework that guides the relationship on both an operational and compliance basis allows for issues to be addressed at a level that is likely more amenable to cooperation and often eliminates legal team involvement.
PharmTech: How do quality agreements enhance the overall quality of pharmaceutical products?
Schmitt: Although the sponsor outsources certain activities, it maintains full responsibility for everything that the contract acceptor does when interfacing with regulatory authorities. Thus, the responsibility for manufacturing safe products of a high quality remains with the sponsor. Therefore, the sponsor has great interest in writing quality agreements that assure the maintenance of high quality and compliance levels by the contractor.
PharmTech: How should quality agreements be designed?
Schmitt: Quality agreements should include clarity in terminology, unambiguously defined roles and responsibilities, and a precisely defined scope of the agreement. These documents are designed for project managers, operational staff, and quality experts. With these users in mind, the language of quality agreements should be appropriate for that audience and not be written like a legal document. Quality agreements should also be written as separate documents from commercial contracts to retain the flexibility to update and change these as needed.
PharmTech: What are some of the mistakes pharma companies make when developing quality agreements?
Schmitt: Issues are more likely to arise when both parties involved are not properly aligned, which may lead to a misunderstanding on expectations. Additionally, gaps may surface in specific areas where the sponsor and contractor have varying levels of expertise, such as information technology. To avoid potential gaps or conflicting details within an agreement, the contractor and sponsor should maintain a close relationship with clear objectives and a mutual understanding of the quality agreement.
Vol. 41, No. 3
When referring to this article, please cite it as S. Haigney, "The Importance of Quality Agreements," Pharmaceutical Technology 41 (3) p. 60, 2017.