FDA Cooperative Manufacturing Arrangements for Licensed Biologics Guidance for Industry

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Cooperative Manufacturing Arrangements for Licensed Biologics Guidance for Industry[附网盘链接]是Food&Drug Administration于之前发布的FDA标准，适用于U.S。

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The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required. II. INTRODUCTION Under section 351(a)(2)(C) of the PHS Act, FDA will approve a biologics license application (BLA) on the basis of a demonstration that the biological product is safe, pure, and potent, and that the facility in which the biological product is manufactured meets standards designed to 1

assure that the biological product continues to be safe, pure, and potent. Section 351(c) of the PHS Act authorizes FDA to conduct a pre-approval inspection of the facility in which the product is manufactured. FDA’s biologics regulations define “manufacturer” as “any legal person or entity engaged in the manufacture of a product subject to license under the PHS Act,” including “any legal person or entity who is an applicant for a license where the applicant assumes responsibility for compliance with the applicable product and establishment standards” (21 Code of Federal Regulations (CFR) 600.3(t)). A manufacturer thus includes a license applicant, who may or may not own the facilities engaged in significant manufacturing steps, when such an applicant assumes responsibility for compliance with the applicable product and establishment standards, including, but not limited to, 21 CFR Parts 210, 211, 600 through 680, and 820. “Manufacture” is defined as “all steps in propagation or manufacture and preparation of products and includes but is not limited to filling, testing, labeling, packaging, and storage by the manufacturer” (21 CFR 600.3(u)). A manufacturer of a biological product must demonstrate responsibility for the manufacturing process as described in its BLA (21 CFR 600.3(t)). For example, a manufacturer must avoid introduction of contaminants during production (21 CFR 610.13). Adequate supervision and control over the manufacture of a biological product has often been achieved by a single manufacturer performing all steps in the production of a product within facilities owned and operated by that manufacturer. However, as described in our 1992 policy statement on cooperative manufacturing arrangements, we have accepted various alternative arrangements involving more than one manufacturer. These alternative manufacturing arrangements include short supply and divided manufacturing, as well as shared and contract manufacturing arrangements. Certain regulatory requirements are partially described for short supply in 21 CFR 601.22 and for divided manufacturing in 21 CFR 600.12(e) and 610.63. We previously published guidance that clarified that small scale or pilot facilities are eligible for licensure provided they are fully qualified and validated, operate in accordance with CGMP 1

FDA has interpreted the definition of the term “potency” in 21 CFR 600.3(s) to include effectiveness. Furthermore, biological products also meet the definition of “drug” or “device” under the Federal Food, Drug, and Cosmetic Act (FDC Act), and therefore are also subject to certain requirements in the FDC Act and its implementing regulations such as current good manufacturing practice (CGMP) provisions.

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