Fda Guidance Contract Manufacturing Quality Agreements

The implementation of a written quality agreement can facilitate compliance with the CGMP, and in particular the 21st CFR 211.22(d), which states that the activities and procedures of the quality unit should be in writing. The FDA recommends that owners and contract entities enter into a written quality agreement to describe their respective roles, responsibilities, and activities related to the CGMP. In short, the FDA expects “owners” to enter into quality written agreements with “contractual entities” in which the parties will define and define the roles and responsibilities of each party to ensure that drugs and pharmaceuticals are manufactured in accordance with current good manufacturing practices. These quality agreements ideally indicate which party carries out which activities and which party is most responsible for full compliance with the GTC in accordance with Section 501(a)(2)(B) of the Act and 21 C.F.R. Parts 210, 211 and 600-680, as these requirements may apply to the product or substance concerned. With these final instructions, the FDA has clarified its scope, particularly with respect to the parties to which it applies. You can find a detailed background on this topic in our blog post on the draft guidelines (here). While the CGMP rules do not explicitly require owners and contractually agreed entities to document their respective responsibilities in order manufacturing agreements, the rules require that the responsibilities and procedures of the quality unit be in writing (21 CFR 211.22(d)). The FDA believes that implementing a written quality agreement facilitates compliance with Section 211.22(d). Therefore, the FDA recommends that owners and contractually agreed entities enter into a written quality agreement in order to retain their respective responsibilities in contract manufacturing agreements. One of the unintended consequences of limiting the scope of the Guidelines is that the CDMs can use them as a pretext to limit the distribution of quality tasks up to the trade programme. This certainly makes the CDMO`s job easier, as they have to juggle the differences between each client`s QMS. At a time when accelerated clinical plans are the norm rather than the exception, the need to maintain a practical allocation of quality responsibility during development is critical to a drug sponsor/owner`s ability to ensure a robust CMC and clinical program.

The new guidelines highlight the need to define who is responsible for installation and equipment activities that impact the production company. This includes defining who supports the qualification of facilities and equipment and the validation of processes. It should also cover support systems for the manufacturing undertaking, including information technology and automated control systems, environmental monitoring and space classification, refuelling services and all other equipment and equipment that needs to be maintained to carry out contractually agreed manufacturing operations in accordance with cGMP. This guide describes the FDA`s current thinking on defining, implementing, and documenting the manufacturing activities of parties involved in contract drug manufacturing, which are subject to the current requirements of the Good Manufacturing Practice (CGMP). In particular, we say how parties involved in the manufacture of contract medicines can use quality agreements to delineate their production activities to ensure compliance with CGMP. The quality agreement must be designed and mutually accepted by the CMO and the customer prior to acceptance of the delivery contract, in order to ensure the identification of all invoiced items and any performance limitations….

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