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 guidelines encourage homeowners to verify and approve most changes before being implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed. 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).
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. » According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines each party`s production activities with respect to CGMP compliance. The agreement should make it clear whether the owner or contracting body (or both) is engaged in certain CGMP activities. (1) A quality agreement should indicate which party will determine component specifications and which party will establish procedures for reviewing, qualifying and tracking component suppliers. It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. Cooperation is essential to any successful business partnership, which is why 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 measures (CAPA) and gap management can lead to dissent, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement. The guidelines also state that quality agreements should be clear with regard to product release. 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.