FDA Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization

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Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization[附网盘链接]是于不久前发布的FDA标准，适用于United States。

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Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization 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 provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls 2

(CMC) information containing emerging technology to FDA. The program is open to companies that intend to include the technology as part of a regulatory submission including investigational new drug applications (IND), original or supplemental new drug applications (NDA), abbreviated new drug applications (ANDA) or biologic license applications (BLA), or 3

application-associated Drug Master Files (DMF) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance. This program does not cover products reviewed by the Center for Biologics Evaluation and Research. Issues in pharmaceutical manufacturing have the potential to significantly impact patient care as failures in quality may result in product recalls and harm to patients. Additionally, product failures or facility, equipment, or manufacturing problems are a major factor leading to 4

disruptions in drug supply. Modernizing manufacturing technology may lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance. For example, contemporary aseptic 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

For the purpose of this document, emerging technology should be novel in the context of the pharmaceutical and related industries and it should have the potential to modernize the pharmaceutical manufacturing body of knowledge related to product quality. Emerging technology will be new to FDA in the context of pharmaceutical quality, with limited prior experience and knowledge. 3

This program is also open to companies or manufacturers that intend to include emerging technology in a drug master file (DMF) that will be referenced by the planned application(s). The steps to request participation in the program are described in section III.B Process. 4

For the purpose of this guidance, the definition of manufacturing includes testing, packaging and labeling operations, and quality control across the product lifecycle (e.g., design, qualification, and commercial manufacturing). Refer to 21 CFR 210.3(b)(12).

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