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FDA Contract Manufacturing Arrangements for Drugs Quality Agreements Guidance for Industry

蒋千琴 12/29/2021 浏览 265 FDA US

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Contract Manufacturing Arrangements for Drugs Quality Agreements Guidance for Industry[附网盘链接]是于不久之前发布的FDA标准，适用于US。

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Contract Manufacturing Arrangements for Drugs Quality Agreements Guidance for Industry[附网盘链接]
Contract Manufacturing Arrangements for Drugs Quality Agreements Guidance for Industry[附网盘链接](截图)

 

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标准部分原文

Contract Manufacturing Arrangements for Drugs: Quality Agreements 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP. For purposes of this guidance, we use certain terms with the following specific meanings: • Current Good Manufacturing Practice (CGMP) refers to requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 501(a)(2)(B), for all drugs and active pharmaceutical ingredients (APIs). For finished human and animal drugs, the term includes applicable requirements under 21 CFR parts 210 and 211. For biologics, the term includes additional applicable requirements under 21 CFR parts 600-680. • Commercial manufacturing refers to manufacturing processes that result in a drug or drugs intended to be marketed, distributed, or sold. • Commercial manufacturing does not include research and development activities, manufacturing of material for investigational new drug studies (e.g., clinical trials, expanded access), or manufacturing of material for veterinary investigational drugs. Although this guidance does not explicitly apply to the manufacture of investigational, developmental, or clinical trial materials, FDA believes that quality agreements can be extremely valuable in delineating the activities of all parties involved in contract research and development arrangements. Many of the principles described in this guidance could be applied in pre-commercial stages of the pharmaceutical life cycle. 1

This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration. 1

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