Therefore, the FDA recommends that owners use a quality system model – an agreement between the parties involved in drug manufacturing, which defines and defines each party`s manufacturing activities in terms of how each party respects the CGMP – as a tool to represent manufacturing activities and support compliance with the rules. « While it has been recommended in some comments that these guidelines fit within the terms of the `contract provider` and `contract processors`, these conditions do not correspond to our objective of showing how parties to a custom manufacturing contract can cooperate in defining, establishing and documenting agreements that represent production activities and ensure compliance with PMCs. » 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 big question is: Why should the Agency provide a guide that only deals with commercial manufacturing? The role of the order manufacturer has grown over the past decade and has expanded to everything from API design to clinical logistics and pharmacovigilance. Commercial manufacturing is the relationship with which the biopharmaceutical industry has the most practical experience and the content and application of the quality agreement are well understood between the owners and the CMO. It is strange that the FDA has chosen to limit the scope of the guidelines to the commercial component when the main challenges for the industry are before commercial manufacturing. Companies should be aware that the FDA intends to review quality agreements when inspecting facilities, which is why the FDA (and we recommend) that quality agreements be separated from other contracts between owners and contract agencies. It is therefore reassuring that the final instructions take a more moderate approach. In accordance with the final guidelines, a « owner » includes, for the purposes of the guidelines, only « manufacturers of APIs, drugs, process materials, finished drugs, including biologics, and combined products. » As with the project, the FDA excludes from the definition of an owner « pharmacies, pharmacies, supermarkets, discount distributors or other retailers that buy finished drugs for sale without a prescription. » In the final manual, it is expressly stated that they do not contain in an owner`s definition « businesses that are exclusively related to the distribution of drugs (. B for example, merchants, brokers, distributors of private labels, their own label distributors). The FDA always encourages these companies to use quality agreements or general concepts of quality agreements if it is useful for these companies to have such an agreement.
08/04/2021