EMA指南（清洁验证）
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page 1 of 16
20 November 2014
EMA/CHMP/ CVMP/ SWP/169430/2012
Committee for Medicinal Products for Human Use (CHMP)
Committee for Medicinal Products for Veterinary Use (CVMP)
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 the
manufacture of different medicinal 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
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
End of consultation (deadline for comments)
结束征求意见（意见截止期）
30 June 2013
2013年6月30日
Adoption by CVMP
兽用药委会采纳
11 September 2014
2014年9月11日
Adopted by Safety Working Party
安全工作组织采纳
October 2014
2014年10月
Adoption by CHMP
人用药委员会采纳
20 November 2014
2014年11月20日
Date for coming into effect 生效日期 01 June 2015 2015年6月
Keywords 关键词
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 2 of 16
Guideline on setting health based exposure limits for use in risk identification in
the manufacture of different medicinal 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
Executive summary 概要..................................................................................... 3
1. Introduction (background) 介绍（背景） .......................................................... 3
2. Scope 范围....................................................................................................... 3
3. Legal basis 法律基础......................................................................................... 4
4. Determination of health based exposure limits 确定基于健康暴露限度.................. 4
4.1 Calculation of a Permitted Daily Exposure (PDE) PDE（每日允许暴露量）计算........................... 4
4.2 Use of clinical data临床数据使用..................................................................................... 6
4.3 Extrapolation to other routes of administration 其他给药途径推断...................................... 6
5. Specific considerations 具体注意事项................................................................. 7
6. Reporting of the PDE determination strategy .PDE确定策略报告....................... 9
7. Implementation 实施.................................................................................... 9
8. Definitions 定义............................................................................................. 9
References:参考文献 ......................................................................................... 10
Annex 附件........................................................................................................ 11
page 3 of 16
Executive summary 概要
When different medicinal products are produced in shared facilities, the potential for cross-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 risk 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 threshold
value (e.g. permitted daily exposure (PDE) 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 levels 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 uncontrolled
release of dust, gases, vapours, aerosols, genetic material or organisms from active substances, other
starting materials, and other products being processed concurrently, as well as from residues on equipment,
and from operators‟ clothing. Due to the perceived risk, certain classes of medicinal product have previously
been required to be manufactured in dedicated or segregated self-contained facilities including, “certain
antibiotics, certain hormones, certain cytotoxics and certain highly active drugs”. Until now no official
guidance 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 and
risk-based approach and refer to a “toxicological evaluation” for establishing threshold values for risk
identification.
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 the
pharmaceutical industry. A variety of approaches are taken in order to establish these limits and often do
not take account of the available pharmacological and toxicological data. Hence, a more scientific case by
case approach is warranted for risk identification and to support risk reduction measures for all classes of
pharmaceutical substances.
清洁是一个风险减少措施和残留限度，因此清洁验证研究被广泛应用于制药行业。采用不同方法以简历这些限度并
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作者：薛定谔的龙猫
分类：专业资料
价格：80质量币
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大小：772.97KB
格式：PDF
时间：2025-11-19
