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. Contractual information, including the Memorandum of Understanding (MoU) and service agreements relating to AoG Consulting Services – Business and Financial Solutions, is available on the Consulting Services page. The following information is additional information and refers specifically to the GCDO panel. In a previous article, I described best practices for trading MSAs and ASAs. I have described the MSA as a document describing the operational, legal and financial framework for the performance of services or the provision of products. I have found that there are several sections within the MSA regarding the QTA. This article will continue the discussion from the perspective of the CTO who will work within the QTA framework, describing how MSA and QTA cooperate and how QTA can be negotiated to achieve the project objectives.
Of these documents, the QTA is often the least priority of the procurement team. However, in practice, the QTA will be the most useful document for companies in the development and clinical phases, as it provides an operating framework and a roadmap for the implementation of quality systems. For verification and negotiation, it is essential to successfully create a multi-function team that includes both quality assurance (QA) and relevant technical expertise. Drawing on the strategies and advice in this article, QTA verification offers the possibility: QTA fills a gap in establishing a strong relationship between the CDMO and the sponsor. It creates a structured framework for how two separate quality systems will work together to manage CGMP activities within the SOW. Its implementation continues to improve due to the experience gained by the pharmaceutical industry and the use of guidelines for the actual resolution of disputes. Since there is not yet an optimized model applicable to all situations, a scientific/technical perspective, in addition to the contribution of the SQ, is an indispensable condition for the verification and negotiation of an effective and useful QTA. In the eyes of the FDA, any activity that is not documented cannot have taken place either.
A quality agreement offers the contractual entity and the owner the opportunity to define the expectations that verify and approve quality documents. It shall describe the minutes of changes to standard operating procedures (SIRs), manufacturing records, specifications, validation documentation and other essential documents relating to the goods or services provided by the contracting entity. The role of both parties in the production and maintenance of original DOCUMENTS in accordance with the PMFR or original copies should be clarified. The agreement should also specify how these recordings will be made available for consultation. It is advantageous to attach a statement that electronic records are kept in accordance with CGMP and kept in an accessible state for the registration periods required by the applicable rules in accordance with FDA requirements. . . .