At the end of the paper, hypothetical scenarios illustrate some common problems in contractual manufacturing agreements. The scenarios also show the FDA`s thinking about a possible solution to the problems. The examples provided should not be exclusive, but provide industry and other stakeholders with some frequent facts and our analysis of those facts. The term «manufacturing» within the meaning of this document includes processing, packaging, rearing, labelling, quality review and exploitation Unit.No activities that are outsourced, the contracting authority`s («owner») quality unit ultimately remains responsible for the approval and refusal of drugs manufactured by the contracting manufacturer (21 CFR 210.3(12)). This differs from Europe, where authorisation (certification by a qualified person) can also be outsourced. The quality agreements discussed in this document are not commercial or commercial agreements and the FDA therefore recommends that quality agreements be separate documents. The EU MSG Guide, Chapter 7, on outsourced activities, clearly sets out expectations for quality contracts. Few details have yet been provided in the United States. The CFR rules do not expressly require contractors to record their respective responsibilities in order manufacturing agreements, but the rules do require that the responsibilities and procedures of the quality unit be in writing (21 CFR 211.22(d)). With the new guidelines, the FDA aims to describe the Authority`s current thinking on defining, defining, and documenting responsibilities in the manufacture of drugs subject to current good management practice (CGMP). The new draft guidance describes the obligations of contracting parties, the delimitation of responsibilities and how to ensure the quality, safety and efficacy of medicinal products in the manufacture of contracts.
It applies to the commercial manufacture of: – pharmaceutical substances (APIs or pharmaceutical or intermediate substances), – finished drugs, – combination products and – biologics The essential sections that can be expected from the FDA are: – Purpose/scope – Conditions (including effective date and end clause) – liability, including communication mechanisms and contacts a. Competence of the quality unit b. Facilities and equipment c. Materials management d. Specific concepts of e.V. products Laboratory controls f. Documentation – Control of modifications and revisions. . . .