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. The FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change. Quality agreements are not an FDA requirement, but the Agency has already sent warning letters to sponsors for failing to create one with its CMO. Implementation of a quality written agreement can facilitate compliance with the CGMP, and in particular with 21 CFR 211.22 (d), which stipulates that the activities and procedures of the quality unit must be written down. The FDA recommends that owners and contract organizations enter into a written quality agreement to describe their respective roles, responsibilities and activities related to the CGMP in drug manufacturing. In short, the fda expects “owners” to enter into quality written agreements with “contractual bodies” in which the parties define and define the roles and responsibilities of each party in ensuring the production of drugs and drugs in accordance with current good manufacturing practices. These quality agreements should ideally indicate which party performs which activities and which party is primarily responsible for full compliance with GMOs in accordance with Section 501 (a) (a) (2) (B) of the Act and 21 C.F.R.
Parts 210, 211 and 600-680, since these rules may apply to the product or substance in question. “When an owner uses a contractual facility, the owner`s quality unit is legally responsible for authorizing or refusing drugs manufactured by the contracting body, including final release,” the guide states. “The rules require that the responsibilities and procedures of the quality unit be written and respected.” “We have made it clear that the guidelines are limited to commercial manufacturing,” the federal registry states. “While the principles formulated may be useful in addressing quality agreements for other types of activities such as clinical research, development or distribution, these are not within the scope of this particular document.” Supplier and supplier quality agreements define the quality conditions of materials or services provided at a production site and used in products or product manufacturing.