It is recommended that the quality agreement be separated from the supply agreement and other commercial or commercial agreements, so that it is independent of the pricing, payment terms, volume of work and other elements of these documents and can therefore be modified or separated independently from each other. Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP. The speed of innovation and competition in the life sciences is relentless. It encourages a growing number of companies to adopt asset-light operating models, which rely heavily on an ecosystem of labour-producing organizations (CMOs). As a result of this trend, the burden of implementing the current Good Manufacturing Practices Directives (PMCs) is increasingly being shared between the companies that own the products and the contractual bodies on which they depend. A strong quality agreement is the first step in ensuring that both parties are accountable and cooperating to comply with the rules imposed by the U.S. Food and Drug Administration (FDA).
This is a mandatory agreement that must be signed with all suppliers providing critical components of a service. Z.B. raw material, sterilization, packaging. In the eyes of the FDA, any activity that is not documented may as well not have occurred. A quality agreement gives the contracting establishment and the owner the opportunity to define the expectations of those who verify and approve quality documents. Protocols should be described for changes to standard operating procedures (SOPS), manufacturing documents, specifications, validation documentation, and all other essential documents relating to products or services provided by the contracting body. The role of both parties in the development and maintenance of original documents or authentic copies compliant with the CGMP must be indicated. The agreement should also clarify how these recordings are easily made available for consultation. It is advantageous to include a statement indicating that electronic records are stored in accordance with CGMP and kept in a searchable condition during the required registration periods, in accordance with FDA requirements. To learn how to optimize the coordination of quality agreements and other order manufacturing functions with digital tools, read the trend letter „3 Ways Contract Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration.” The FDA does not have a specific policy for quality agreements between medical device companies and CMOs that provide them with services.