中英文对照-欧盟共享设施生产药品指南-草案.docx

13 December 2012 2012年12月13日EMA/CHMP/ CVMP/ SWP/169430/2012Committee for medicinal products for human use (CHMP) 人用药品委员会(CHMP)Committee for medicinal products for veterinary use (CVMP) 兽用药委员会(CVMP)Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities 在共享设施中生产不同药品用风险辨识建立健康暴露限度指南Draft 草案Draft Agreed by Safety Working Party 安全工作组同意草案December 2012 2012年12月Adoption by CVMP for release for consultation 兽用药委员会采用发放征求意见November 2012 2012年11月Adoption by CHMP for release for consultation 人用药委员会采用发放征求意见13 December 2012 2012年12月13日Start of consultation 开始征求意见08 January 2013 2013年01月08日End of consultation (deadline for comments) 结束征求意见(意见截止期)30 June 2013 2013年06月30日Comments should be provided using this  HYPERLINK http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004016.doc template. The completed comments form should be sent to  HYPERLINK mailto:SWP-H@ema.europa.eu SWP-H@ema.europa.eu 提交意见应使用本模板。完整的意见格式应发送到 HYPERLINK mailto:SWP-H@ema.europa.eu SWP-H@ema.europa.eu。Keywords 关键词Shared facilities, risk identification, exposure limits 共享设施、风险辨识、暴露限度Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities 在共享设施中生产不同药品用风险辨识建立健康暴露限度指南Executive summary 概要When different medicinal products are produced in shared facilities, the potential for cross-contamination becomes an issue for concern. Hence, residues of an active substance which remain after cleaning of production equipment and other product contact surfaces may contaminate other medicinal products produced in the same facility. Active substances provide a medicinal benefit to the intended patient or target animal; however as a cross over contaminant, they provide no benefit to the patient or target animal and may even pose a risk. Hence, the presence of active s