Chapter 7 of the EU GMP Guide on Outsourced Activities clearly sets out expectations for quality contracts. In the United States, few details have been given so far. CFR regulations do not explicitly require contracting parties to document their respective responsibilities in contracting agreements, but the rules require that the responsibilities and procedures of the quality unit be written (21 CFR 211.22 (d)). With this new guide, the FDA intends to describe the Authority`s current thinking on defining, implementing and documenting the manufacturing responsibilities of drugs subject to current good manufacturing practice (CGMP). It is also important to note that, as fda acknowledged in the draft guidelines, the FDA cGMP “does not expressly require owners and contract agencies to document their respective responsibilities in contract manufacturing agreements.” The full citation of the draft guidelines indicates that the guidelines invite owners to review and approve most of the changes before being implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed. With this final guide, the FDA has clarified its scope, particularly with respect to the parts to which it applies. You will find a detailed context on this topic in our blog post on the draft guidelines (here).
In the draft guidelines, the FDA defined an owner as each party that “introduces (or causes) the introduction of a drug into intergovernmental commerce. As we said in our previous article, this definition was so broad that it seemed highly unlikely that the FDA would actually intend to apply the guidelines to all entities that would meet that definition (for example. B distributors). Not only did it seem illogical to require distributors or other “owners” in effluents to be responsible for certain non-delegable cGMP requirements, such as product release, but it should also have resulted in the repeal of Section 303 (c) of the Act authorizing down stream companies to rely on written product warranties from Up Stream manufacturers. First, it is important to note that the new guidelines reflect the FDA`s current thinking on commercial production relationships and not on research and development and apply to the following categories: human drugs, veterinary drugs, certain combined products, biologics and biotechnology products, finished products, APIs, drugs, process materials and active ingredients of combined drugs. The guidelines do not apply to the following types of products: Type A medical items and medical foods, medical devices, dietary supplements or human cells, tissues or cellular or tissue products regulated in accordance with Section 300 of the Public Health Service Act and 21 CFR Part 1271. Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP. A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors.
However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. A quality agreement should at least define the obligations and responsibilities of each party in the following basic elements mentioned in the guidelines: the new draft guidelines outline the obligations of the parties, the delineation of responsibilities and how to ensure the quality, safety and effectiveness of medicines in the manufacture of orders. It applies to the industrial manufacture of: – active substances (APIs or their intermediaries), – finished medicines,