PIC S GMP-2018中文原版资料.pdfVIP

史上最严 PIC/S GMP-2018 发布，全文解读 2018 年6 月20 日，PIC / S 官网发布了新的GMP 指南 （PE 009-14），新的指南 修订了以下章节和附录： 第三章：“厂房和设备” 第五章：“生产” 第八章：“投诉和召回” 附录17 ：“实时放行检验和参数放行” 修订后的GMP 指南 （PE 009-14）将于2018 年7 月1 日生效。 新增及修订的条款翻译如下： PE 009-14 PIC/S GMP GUIDE PIC/S GMP 指南 CHAPTER 3 PREMISES AND EQUIPMENT 第三章 厂房设施和设备 Production Areas 生产区 3.6 Cross-contamination should be prevented for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross-contamination should be commensurate with the risks. Quality Risk Management principles should be used to assess and control the risks. 应对生产设施采用适当的设计和操作以避免任何产品之间的交叉污染。 防止交叉污染的措施应与风险相适应。应采用质量风险管理原则对这些 风险进行评估和控制。 Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products. 根据风险的水平，生产和/或包装操作应有专用的厂房设施及设备以控制 来自其他产品的风险 Dedicated facilities are required for manufacturing when a medicinal product presents a risk because 当产品因下列原因存在风险时，应使用专用设施进行生产 ： i. the risk cannot be adequately controlled by operational and/ or technical measures, 风险无法通过操作和/或技术措施充分控制 ii. scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta-lactams) or 来自毒性评价的科学数据无法支持风险的可控性 （例如，高致敏性物料， 如β酰胺类）或 iii. relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method. 由毒性评价数据推倒出来的残留限度尚无有效的分析方法实现检测。 Further guidance can be found in Chapter 5 and in Annexes 2, 3, 4, 5 6. 更多指南详见章节 5和附录 2、3、4、56. CHAPTER 5 PRODUCTION 第五章 生产 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 防止生产过程交叉污染 5.17. Normally, the production of non-medicinal products should be avoided in areas and with equipment destined for the production of med