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1、北京齐力佳咨询提供2015page # of 16北京齐力佳咨询提供2015page # of 16北京齐力佳咨询提供2015Draft Agreed by Safety Worki ng Party 安全工作组同意草案Adoption by CVMP for release for consultation 兽用药委员会采用发放征求意见Adoption by CHMP for release for consultation 人用药委员会采用发放征求意见End of consultation (deadline for comments) 结束征求意见(意见截止期)Adoption by C
2、VMP兽用药委会采纳Adopted by Safety Working Party安全工作组织采纳Adoption by CHMP人用药委员会采纳Date for coming into effect生效日期Keywords 关键词EUROPEAN MEDICINES AGENCY20 November 2014EMA/CHMP/ CVMP/ SWP/169430/2012Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP)
3、 2014年11月20日EMA/CHMP/ CVMP/ SWP/169430/2012欧洲药品管理局人用医药产品委员会欧洲药品管理局兽用医药产品委员会Guideline on setting health based exposure limits for use in risk identification in themanu facture of differe nt medici nal products in shared facilities在共用设施中生产不同药品使用风险辨识建立健康暴露限度指南December 20122012年12月November 20122012年11月1
4、3 December 20122012年12月13日30 June 20132013年6月30日11 September 20142014年9月11日October 20142014年10月20 November 20142014年11月20日01 June 20152015 年 6 月Shared facilities, risk identification, exposure limits, toxicological data, residual active substances, PDE.共享设施，风险辨识，暴露限度， 毒理学数据，残留活性物质，每日 允许暴露量page # of
5、16北京齐力佳咨询提供2015Guideline on setting health based exposure limits for use in risk identification in the manu facture of differe nt medici nal products in shared facilities 在共用设施中生产不同药品使用风险辨识建立健康暴露限度指南Table of contents目录page # of 16page # of 16Executive summary概要1. Introduction (background)介绍(背景)2. Sc
6、ope 范围3. Legal basis 法律基础4. Determ in ati on of health based exposure limits4.1 Calculatio n of a Permitted Daily Exposure (PDE)4.2 Use of clinical data临床数据使用 4.3 Extrapolati on to other routes of adm ini strati on5. Specific considerations具体注意事项.6. Report ing of the PDE determ in ati on strategy .7
7、. Implementation实施33.4确定基于健康暴露限度4PDE （每日允许暴露量）计算 4其他给药途径推断 67PDE确定策略报告9page # of 16page # of 168. Definitions 定义Referen ces:参考文献10page # of 16page # of 1611Annex 附件page # of 16北京齐力佳咨询提供2015Executive summary概要When different medicinal products are produced in shared facilities, the potential for cross
8、-contamination is a concern. Medicinal products provide a benefit to the intended patient or target animal; however as a cross contaminant, they provide no benefit to the patient or target animal and may even pose a risk. Hence, the presence of such contaminants should be managed according to the ri
9、sk posed which in turn are related to levels that can be considered safe for all populations. To this end, health based limits through the derivation of a safe threshold value should be employed to identify the risks posed.The derivation of such a thresholdvalue （e.g. permitted daily exposure （PDE）
10、or threshold of toxicological concern （TTC） should be the result of a structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data. Deviation from the main approach highlighted in this guideline to derive such safe threshold l
11、evels could be accepted if adequately justified.当在共用设施生产不同的药用产品时，潜在交叉污染是受到关注的。药用产品提供为患者或者目标动物提供预期医 疗溢处，然而，交叉污染，没有向病人或者目标动物提供任何溢处，甚至可能带来风险。因此，应限制药用产品污 染物在一个对所有人群认为是安全的水平。为此，基于健康限度，通过推导安全阀值应该被用于识别风险。偏离阀 值（如，每日允许暴露（PDE ）或毒理学相关阀值（TTC ）应来自结构化的对包括非临床和临床数据的所有药理 学与毒理学数据科学评价。如果有充分合理的理由，来自这条指导原则中强调的主要方法获得的安全阀
12、值水平偏离 可以接受。1. Introduction （background）第一章：介绍（背景）During the manufacture of medicinal products accidental cross-contamination can result from the uncontrolledrelease of dust, gases, vapours, aerosols, genetic material or organisms from active substances, other starting materials, and other products b
13、eing processed concurrently, as well as from residues on equipment, and from operators? clothing.Due to the perceived risk, certain classes of medicinal product have previouslybeen required to be manufactured in dedicated or segregated self-contained facilities including,certainantibiotics, certain
14、hormones, certaincytotoxics and certain highly active drugs ” Until now no officialguidance is available in order to assist manufacturers to differentiate between individual products within these specified classes.Chapters 3 and 5 of the GMP guideline have been revised to promote a science andrisk-
15、based approach and refer to a“ toxicological evaluation” for establishing threshold values for riskidentification.医药产品生产过程中无法控制的意外可能导致交叉污染，如粉尘、气体、蒸汽、气溶胶，遗传物质或生物活性物质，其他原料、或者其他产品同时生产时，以及设备和操作人员衣服残留。由于预知风险，某些类型的医药产品以前需 要专用的或隔离的独立的生产设施，包括“某些抗生素、某些激素、某些细胞毒性和某些高活性药物”。直到现在 没有官方的指南能够帮助生产商去区分这些单个产品和这些特定类别之间的不同。GMP指南修订了章节3和5，用于促进科学和风险基础的方法，参见“毒理学评价”用于建立风险辨识阀值。Cleaning is a risk reducing measure and carry-over limits for cleaning validation studies are widely used in
