An effective quality agreement defines the specific sites on which the contracting establishment will carry out manufacturing operations, including specific services to be provided at each site. 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 beneficial to add a statement that electronic records are retained in accordance with CGMP and kept in an accessible condition during the necessary registration windows defined by the applicable rules in accordance with FDA requirements. Part of the agreement should address specific product-specific considerations. It should also define how owners pass on knowledge, such as product information and process development, to contracting entities to ensure that manufacturing is compatible with CGMP. The speed of innovation and competition in the life sciences is relentless. This is prompting more and more companies to adopt light asset operating models, which rely heavily on an ecosystem of order manufacturing organizations (CMOs).

As a result of this trend, the burden of complying with the current Good Manufacturing Practices Guidelines (GMPCs) is increasingly shared between the companies that own products and the contract establishments on which they depend. A strong quality agreement is the first step for both parties to be responsible and cooperate to comply with the rules imposed by the US Food and Drug Administration (FDA). Cooperation is essential for any successful business partnership, so it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization. Processes such as Corrective and Preventive Action (CAPA) and gap management have the potential to cause disagreement, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement. . . .