FDA CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports

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CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于US。

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标准部分原文

Draft — Not for Implementation 1 CMC Postapproval Manufacturing Changes for Specified 2 Biological Products To Be Documented in Annual Reports 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff 10 responsible for this guidance as listed on the title page. 11 12 13 14 I. INTRODUCTION 15 16 This guidance provides recommendations to holders of biologics license applications (BLAs) 17 for specified products regarding the types of changes to an approved BLA to be documented in 18 an annual report under 21 CFR 601.12. Specifically, the guidance describes chemistry, 19 manufacturing, and controls (CMC) postapproval manufacturing changes that we (FDA or 20 Agency) generally consider to have a minimal potential to have an adverse effect on product 2

21 quality. Under FDA regulations, postapproval changes in the product, production process, 22 quality controls, equipment, facilities, or responsible personnel that have a minimal potential to 23 have an adverse effect on product quality must be documented by applicants in an annual 3

24 report. 25 26 This guidance applies to all of the specified categories of biological products in 21 CFR 27 601.2(a). The guidance does not apply to blood-derived products, in vitro diagnostics, cellular 4

28 and gene therapy products, and vaccines and related products ; however, a BLA holder for any 29 other naturally derived biological product should discuss with FDA whether the 30 recommendations in this guidance apply to his or her BLA. 31 32 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 33 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 1

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

In this guidance, the term product quality refers to the “identity, strength, quality, purity, or potency of the product as [these factors] may relate to the safety or effectiveness” of the biological product (21 CFR 601.12(d)(1)). 3

See 21 CFR 601.12(d). 4

For a description of these product classes, see guidance for industry Changes to an Approved Application: Biological Products. FDA updates guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or the FDA Biologics guidance Web page at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 1

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