FDA Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

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Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products[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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1 Allowable Excess Volume and Labeled Vial Fill Size in Injectable 2 Drug and Biological Products 2

3 Guidance for Industry 4 5 6 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 7 this topic. It does not establish any rights for any person and is not binding on FDA or the public. You 8 can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 9 To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 10 title page. 11 12 13 14 15 I. INTRODUCTION 16 17 This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and 18 Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current 19 thinking on allowable excess volume and labeled vial fill size in injectable drug and biological 20 products. It replaces the draft of the same name that was published on March 14, 2014 (79 FR 21 14517). Specifically, the guidance clarifies the FDA regulatory requirements and 22 recommendations pertaining to allowable excess volume in injectable vials and describes when 3

23 justification is needed for a proposed excess volume in these injectable drug products. This 24 guidance also discusses the importance of appropriate fill volumes for injectable drug products 25 and recommends that labeled vial fill sizes be appropriate for the intended use and dosing of the 26 drug product. 27 28 This guidance addresses withdrawable volume and labeled vial fill size for injectable drug 29 products that are packaged in vials and ampules, including products that require reconstitution. 30 It does not address injectable drug products in other packaging types (e.g., prefilled syringe 31 package systems and intravenous infusion bags) or noninjectable products, because there may be 32 unique considerations for these packaging configurations. The recommendations in this 33 guidance apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), 34 biologics license applications (BLAs), as well as supplements or other changes to these 35 applications for new packaging or other changes that may affect the fill volume. 36 37 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 38 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 39 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 1

The term vial used throughout this guidance refers to both vial and ampule package types. 2

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research in collaboration with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 3

The term drug used throughout this guidance refers to drugs, including biological drug products. 1

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