The FDA Quality Agreements document is based on ICH Q10 Pharmaceutical Quality Systems, which states that the owner is ultimately responsible for ensuring that “processes are in place to ensure the control of outsourced activities and the quality of the equipment purchased.” The recommendation is that the owner become quality management when assessing the suitability and competence of potential contractors prior to outsourcing through audits (or other qualification criteria) and regularly assessing the performance of “accredited” contracting bodies. On the other hand, the new guide gives a general overview of the areas to be included in a quality agreement. It contains sections relating to manufacturing activities: the EU and the FDA have recently issued regulatory guidelines for: in order to bring clarity and consistency in these quality contracts: contractual manufacturing arrangements for drugs: Quality Agreements Guidance document (here) stipulate that the FDA considers that the responsibility of the owner (which uses the services of contracting agencies) implies the responsibility of the quality unit to approve or deny the product or service of the contracting body (whether it is testing, processing, packaging or storage). In addition, as part of a comprehensive quality assurance model, the owner should use a quality written agreement when using the services of a contracting agency, so that the corresponding roles/responsibilities related to the CGMP are clear for the services to be provided. The quality agreement should also include quality specifications and define the communication mechanisms between the owner and the contracting body. The FDA considers the quality agreement to be a key to facilitating compliance with the CGMP on issues relating to 21 CFR 211.22, which stipulates that quality units must be written activities and procedures. This guide describes the FDA`s current thinking on the definition, implementation and documentation of the manufacturing activities of the parties involved in the manufacture of contract drugs subject to the current requirements for good manufacturing practices (CGMP). In particular, we describe how parties involved in drug manufacturing can use quality agreements to define their manufacturing activities to ensure compliance with PMCs. As a general rule, a “Definitions” section should be part of all quality agreements. As long as each party does not have a clear and reciprocal understanding of the terminology used in the agreement, it is only a matter of time before communication problems arise that may compromise the cGMP compliance of outsourced activities. The new guidance document defines the elements of a quality agreement: object/extended; definitions; Dispute resolution Manufacturing activities and document lifecycle. The core of the quality agreement defines the roles and responsibilities of manufacturing activities (owner-outsourced services), which may include contract testing (laboratory controls) depending on the size of the contract.
It is recommended that the quality agreement for contractual controls refer to the procedures/process by which all test results performed by the contracting body are communicated to the owner for evaluation. The agreement should also include the mechanism for transferring analytical testing methods between the owner and the contracting body. It is of the utmost importance that the quality agreement defines the routine verification procedures of the owners of the laboratory controls of the contracting body to ensure that the laboratory operates in a controlled state in accordance with the CGMP. This review should include confirmation by the owner that the contracting body has a data integrity governance system.