Whenever a contractor or ORGANISATION is used, including agreements between different departments of the same company, regardless of the physical location of the parties involved, a quality agreement should be reached. The agreement should cover all aspects of the project affecting the identity, quality, safety, efficiency and purity of a product. Items that may affect the contractor`s or client`s compliance status should also be included. To avoid misunderstanding, a glossary that defines keywords, acronyms and abbreviations is essential. It is essential that everyone knows what is meant by any term used in the quality agreement. This is especially true when contracts with non-U.S. companies. terminology can be very different. Make sure you clearly define all referenced documents. The scope of the quality agreement should include several compliance activities, such as qualification, calibration and maintenance of analytical tools and manufacturing equipment; Validation of computer systems, analysis methods and manufacturing processes; The specifications used to pass or fail to pass analytical tests Processing, storing and preparing; Receiving, analyzing and communicating samples Collecting and managing laboratory records Gap management and change control. A real example of compliance [FDA] 483 in quality agreements is a contract verification body that indicates that it does not comply with a quality agreement on the destruction of the remaining samples with the approval of the contracting entity.
This relates to the importance of defining clearly defined roles, respecting roles within an agreement and matching CGMP`s expectations. 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. A quality agreement should include at least the following sections: Fda guidelines further state (in case examples), “Regardless of who the products are tested, the owners` quality units are ultimately responsible for manufacturing the products in accordance with the CGMP. A quality agreement will not change that. The FDA could name the owners… for non-assessment, qualification, review and control of their contractual bodies.
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 U.S. rules.