The new draft guidelines outline the obligations of the parties, the definition 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 active substances or their intermediaries), finished drugs, combined products and biologic drugs At the end of the document, hypothetical scenarios illustrate some common problems in contractual manufacturing agreements. Scenarios also show reflection on a possible solution to the problems. The examples cited should not be exclusive, but should provide industry and other stakeholders with some frequent factual patterns and our analysis of these facts. The term “manufacturing” within the meaning of this document includes processing, packaging, thinking and labelling, quality testing and operations Unit.No subject matter whose activities are outsourced, the quality entity of the contracting entity (“owner”) remains ultimately responsible for the approval and refusal of drugs manufactured by the contract manufacturer (21 CFR 210.3 (12)). This is not the case in Europe, where authorisation (certification by a qualified person) can also be outsourced. The quality agreements that are dealt with in this document are not commercial or commercial agreements, so the FDA recommends that quality agreements be separate documents. 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). The basic sections that could be expected of the FDA are: – purpose/scope – conditions (including the validity date and termination clause) – dispute resolution – responsibilities, including communication mechanisms and contacts has. Responsibilities of quality units b.
