FDA Chemistry, Manufacturing, and Controls Changes to an Approved Application Certain Biological Products

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Chemistry, Manufacturing, and Controls Changes to an Approved Application Certain Biological Products[附网盘链接]是Food And Drug Administration于之前发布的FDA标准，适用于U.S。

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Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products 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 staff responsible for this guidance as listed on the title page. I. INTRODUCTION We (FDA or Agency) are providing guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA) as specified in Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12) (i.e., post-approval changes) (Refs. 1 and 2). The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes under 21 CFR 601.12. This guidance finalizes the draft guidance, “Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products” dated December 2017, and supersedes the guidance entitled “Guidance for Industry: Changes to an Approved Application: Biological Products” dated 1997 (July 1997 guidance). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. II. BACKGROUND Applicants and manufacturers (“applicants”), for a variety of reasons, often implement changes to the product, production process, quality controls, equipment, facilities, or responsible personnel, or labeling approved in an application for licensed biological products (for purposes of this document, “manufacturing changes”). An applicant must notify the Agency about each manufacturing change to an approved BLA under 21 CFR 601.12. If the applicant makes a manufacturing change to an approved BLA, the applicant must also conform to other applicable laws and regulations, including the current good manufacturing practice (CGMP) requirements of section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 1

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