FDA Issues Draft Guidance on Vial Filling Size

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-14-2014 16:42


FDA has issued a draft guidance, Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products, to provide the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on allowable excess volume and labeled vial fill size in injectable drug and  biological products. Specifically, the draft guidance clarifies the FDA regulatory requirements and recommendations pertaining to allowable excess volume in injectable vials and describes when justification is needed for a proposed excess volume in these injectable drug products. This guidance also discusses the importance of appropriate packaging sizes for injectable drug products and recommends that labeled vial-fill sizes be appropriate for the intended use and dosing of the drug product.

This guidance addresses fill and packaging issues for injectable drug products that are packaged in vials and ampules, including products that require reconstitution. It does not address injectable drug products in other packaging types (e.g., prefilled syringe package systems and intravenous infusion bags) or noninjectable products, because there may be unique  considerations for these packaging configurations. The recommendations in this guidance apply to new drug applications, abbreviated new drug applications, biologics license applications as well as new packaging supplements to these existing applications submitted to CDER and CBER.

Source: FDA

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