FDA Comparability Protocols for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information

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Comparability Protocols for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information[附网盘链接]是FDA于不久前发布的FDA标准，适用于美国。

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Draft — Not for Implementation 1 Comparability Protocols for Human Drugs and Biologics: 2 Chemistry, Manufacturing, and Controls Information 1

3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration 8 (FDA or Agency) on this topic. With the exception of the discussion regarding submission of changes to a 2

9 comparability protocol in a changes being effected supplement, it does not establish any rights for any person 10 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of 11 the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 I. INTRODUCTION 16 17 This guidance provides recommendations to holders of applications for human drugs and biologics on 18 implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use 19 of a comparability protocol (CP). It replaces the draft guidance that published in February 2003, 20 titled Comparability Protocols: Chemistry, Manufacturing, and Controls Information. 21 22 A CP is a comprehensive, prospectively written plan for assessing the effect of a proposed CMC 23 postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a 3

24 biological product (i.e., product), as these factors may relate to the safety or effectiveness of the 4

25 product (i.e., product quality). Submission of a CP in an original application or prior approval 26 supplement (PAS) allows the agency to review a description of one or more proposed CMC 27 postapproval changes, supporting information including any analysis and risk assessment activities, a 28 plan to implement the change(s), and, if appropriate, a proposed reduced reporting category for the 29 change(s). Approval of the original application containing the CP or a subsequent PAS containing the 30 CP can provide an applicant with an agreed-upon plan to implement the specified change(s), and in 31 many cases, a justification to report the change(s) in a reduced reporting category, contingent upon 32 the applicant’s analysis of the data from the implementation of the change. In many cases, using a 33 CP will facilitate the subsequent implementation and reporting of CMC changes, which could result 34 in moving a product into distribution or facilitating a proactive approach to reinforcing the drug 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research, in cooperation with the Center for Biologics Evaluation and Research, at the Food and Drug Administration (FDA). 2

This limited portion of the guidance will have binding effect upon finalization, pursuant to section 506A of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.70. 3

In this guidance, the term “product” refers to drug product and biological product (see 21 CFR 314.3 and 600.3) and to their constituent drug substances. 4

In this guidance, the term “product quality” refers to product identity, strength, quality, purity, and potency, as these factors may relate to the safety or effectiveness of the product (see footnote 2). 1 *Insofar as section V of this guidance sets forth that certain modifications to an approved comparability protocol may be submitted in changes being effected supplements rather than prior approval supplements, it will have binding effect upon

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