首页 > 资讯 > 资讯公开 > 中美药监局警示天津爆炸对装运药品的潜在污染

出自识林

2015-12-24 FDA

美国FDA官网消息：

2015年12月22日，FDA向药品配药机构和生产商发出警示，从中国天津装运的药品可能存在化学污染风险。自2015年8月天津东疆港区瑞海国际物流有限公司的化学品仓库发生两次巨大爆炸后，FDA提高了对装运药品的监控。

提高监控后，在来自天津天药药业股份有限公司（天津天药）装运的两批药品中检测到氢氰酸污染，天津天药距爆炸地点约30公里。天津天药自爆炸后还发送了另外两批药品到美国，在装运货物中没有检测到氢氰酸后已放行。这些货物可能已用于药房配药。

受污染的货物已经被阻止并将不被允许进入美国。FDA正在与中国食品药品监督管理总局（CFDA）合作解决这一问题。

FDA提高监控的目的是防止进口到美国的药品可能受到与爆炸有关的有毒化学品的污染。虽然有关爆炸的信息有限，但在爆炸现场已发现超过40种不同类型的化学物质.

从天津地区采取适当的预防措施获得药品（包括成品药、原料药和辅料）以在产品发运和/或用于进一步生产或配药或成品之前确保产品质量是企业的责任。

生产商和配药商必须了解所获成分的材料来源。在美国的企业对所订购或接收的原料药如有疑问，尤其是来自天津地区的药品成分，应联系国外生产商获取信息。企业必须保持警惕，以确保所有货物免受与爆炸有关的污染影响，并且确保不会以任何方式受到污染。

更多详情请查看FDA官网Tianjin drug shipments

中国食药总局官网消息：

国家食品药品监督管理总局新闻发言人通报天津天药药业股份有限公司出口美国产品外包装检出氰化物的有关情况
2015年12月23日 原文地址

12月15日我局接到美国食品药品管理局（FDA）关于天津天药药业股份有限公司出口美国的泼尼松、地塞米松和地塞米松磷酸钠原料药外包装检出氰化物的通报后，即组织有关技术机构进行检查和检测，在该企业库存与出口美国同批次产品的外包装检出痕量（低于极微量）氰化物，与FDA检测量值相当，包装内药品未受到污染。我局已通报天津市关注此事，并采取措施确保出厂药品不被污染，保障公众用药安全。

编译：识林-椒

FDA官网原文：

[12/22/2015] FDA is alerting drug compounders and manufacturers that drug shipments from Tianjin, China may be at risk of chemical contamination. FDA increased surveillance of drug shipments following two massive explosions at Tianjin Dongjiang Port Ruihai International Logistics Co., a chemical warehouse, in August 2015.

The increased surveillance resulted in the detection of hydrogen cyanide contamination in two shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd. (Tianjin Tianyao) located in Tianjian, approximately 30 kilometers (18 miles) from the explosion site. Tianjin Tianyao also sent two other drug shipments to the U.S., since the explosion, that were tested and released after hydrogen cyanide was not detected in the shipments. The shipments appear to have been intended for use in pharmacy compounding.

The contaminated shipments have been stopped and will not be allowed into the United States. The FDA is working with the Chinese Food and Drug Administration (CFDA) on this issue.

FDA's increased monitoring is intended to prevent the import into the U.S. of drugs that may be contaminated by toxic chemicals associated with the explosions. While information related to the explosion is limited, more than 40 different types of chemicals were discovered at the blast site.

It is the responsibility of companies that obtain drugs - including finished drug products, active pharmaceutical ingredients (APIs) and excipients - from the Tianjin City region to take appropriate precautions to ensure the quality of these products before they are distributed and/or used to further manufacture or compound drugs or drug products.

Manufacturers and compounders obtaining drug ingredients must know the source of the ingredients. Companies in the U.S. with questions about the drug ingredients they order or receive, particularly from the Tianjin City area, should contact the foreign manufacturer for information. Companies must remain vigilant to ensure that all shipments are free from contamination associated with the explosion and not contaminated in any way.