GMP News
30/07/2015
New FDA Guidance for Industry on the Allowable Excess Volume in Injectable Drug Products
新FDA行业指南：关于注射药品允许溢装量
Usually, there is a slight overfilling in small volume injectable drug products, especially for biological active ingredients, in order to guarantee the excess volume. In its actual FDA Guidance for Industry "Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products" finalised for 24 June 2015 the FDA clarifies its point of view and the corresponding requirements. The guidance for industry only refers to drugs in ampules or vials that are intended for injection. Other packaging types (such as prefilled syringes and intravenous infusion bags) or noninjectable products are not mentioned.
通常，小容量注射药品会有较小的溢装，特别是对于生物活性成分，这样来保证有多余的数量。在此次FDA2015年7月24日定稿的行业指南“注射药和生物制品允许溢装量和标示西林瓶规格”中，FDA澄清其观点和相关的要求。行业指南只是针对了注射用安瓿瓶或西林瓶装的药品。其它包装类型（例如预装针剂和静脉注射包）或非注射药品则没有提及。
Background:背景
Injectable vial misuse, including unsafe handling and injection techniques, has led to more cases of vial contamination - especially in multiple-dose containers - and with that to an increased risk of bloodborne illness transmission between patients. According to the FDA inappropriate excess volume and labelled vial fill sizes are two factors that may contribute to this misuse.
注射西林瓶误用，包括不安全处理和注射技术，已导致多起西林瓶污染—特别是在多剂量容器中---这样增加了患者间血液来源的疾病传播。根据FDA的意见，溢装量和标识的西林瓶灌装量是导致误用的两个因素。
With its recommendations in this guidance the FDA intends to prevent an overfilling of vials without sufficient reasons. The details of the final guidance for industry "Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products" were already commented in the news "New FDA Guidance to Avoid Overfill in Vials" on the draft of the document on 31 March 2014.
在该指南的建议中，FDA意在防止没有科学依据的溢装。终稿行业指南的详细内容已在2014年3月的文件草案新闻中做出了评估。