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20150225 ECA新闻：EU GMP指南第1部分第5章新旧交叉对照表（2015年3月1日生效） 2015-02-27 20:17:34| 分类： ECA新闻
来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015126103432277/ GMP News
25/02/2015 Matrix compares old vs new EU GMP Guide Part I, Chapter 5 - effective as of 1 March 2015 EU GMP指南第1部分第5章新旧交叉对照表（2015年3月1日生效） Starting with the 1 March 2015 the revised Chapter 3 (Premises and Equipment) and Chapter 5 (Production) of the EU GMP Guide Part I for Medicinal Products for Human and Veterinary Use will become effective (see also our GMP news from 12 February 2015). Until then the versions issued with the entire GMP Guide in the Nineties are still valid. 修订后的人药和兽药产品EU GMP第一部分第3章（设施与设备）和第5章（生产）将自2015年3月1日开始生效（参见2015年2月12日我们的GMP新闻）。此前整个GMP指南仍是有效的。 The following matrix provides you with a compact overview of the changes in both Chapters. The changes in Chapter 3 are actually easy to compare. The principles and the Chapters 3.1 - 3.5 and 3.7 - 3.27 are identical. Only Chapter 3.6 now mentions quality risk management for the risk control as well as requirements for the use of Dedicated Facilities. In addition there are indications on other passages to be considered in Chapter 5 and in the Annexes 2-6. Further, a footnote also refers to the EMA Guideline on Shared Facilities. 以下交叉对照表将给你提供变更前后2章的总体变化情况。第3章的变更实际上很容易比较。3.1到3.5和3.7到3.27是一样的，只有3.6节现在提到了风险控制中的质量风险管理，以及使用专用设施的要求。另外，第5章和附录2-6中的其它段落也提到一些。还有，增加了一条脚注来引用到EMA的共用设施指南。 A little more difficult to compare is Chapter 5. The following matrix sententiously summarises the changes - comparing them by the numbers of both the new and the old document. It allows you to quickly compare it with an existing QM system and can thus be used for a "GAP" analysis, a self inspection or for audits. 第5章则有点不好比较。以下对照表概括了这些变更—将新旧版本按编号进行比较，这样你可很快地将现有QM体系与其比较，从而进行差距分析和自检。 EU GMP Guide Part I, Chapter 5
Version effective as of 1 March 2015 (new Version) | EU GMP Guide Part I, Chapter 5,
Version effective until 28 Feb 2015 (old Version) | Principles | Principles | General Requirements | General Requirements | 5.1 - 5.16 | 5.1 - 5.16 | Prevention of Cross Contamination in Production | Prevention of Cross Contamination in Production | 5.17
(supplemented by
- Exception for the production of non-medicinal products with reference to Chapter 3
- Prohibition of production and storage of poisons, pesticides and herbicides) | 5.17 | 5.18
(supplemented by
- Genetic material, APIs or raw materials)
- Mention of hormones, cytostatic drugs, highly effective substances are omitted) | 5.18 | 5.19
(supplemented by:
- Prevention of cross contamination through the design, with reference to Chapter 3) | 5.19 | 5.20 (with reference to EMA Guideline on Shared Facilities) | - | 5.21 | - | 5.22 | 5.20 | Validation | Validation | 5.23 -5.26 | 5.21-5.24 | Raw Materials | Raw Materials | 5.27
(supplemented by:
- Supplier qualification) | 5.25, 5.26 | 5.28
(supplemented by:
- Quality agreement
- Discussion of specifications with the supplier are omitted) | 5.26 | 5.29 | - | 5.30
(supplemented by:
- Documentation of tests) | 5.27 | 5.31 - 5.34 | 5.28 - 5.31 | 5.35 | - | 5.36 | - | 5.37 - 5.39 | 5.32 - 5.34 | Processing Steps: Intermediates and Bulk Ware | Processing Steps: Intermediates and Bulk Ware | 5.40 - 5.44 | 5.35 - 5.39 | Packaging Materials | Packaging Materials | 5.45
(supplemented by:
- Selection, qualification, support of suppliers of primary and printed packaging materials) | 5.40 | 5.46 - 5.48 | 5.41 - 5.43 | Packaging Processes | Packaging Processes | 5.49 - 5.62 | 5.44 - 5.57 | Finished Products | Finished Products | 5.63 - 5.65 | 5.58 - 5.60 | Rejected, recycled and returned Materials | Rejected, recycled and returned Materials | 5.66 - 5.70 | 5.61 - 5.65 | 5.71 | - | EU GMP指南第1部分，第5章 2015年3月1日生效（新版） | EU GMP第1部分，第5章，有效期截止2015年2月28日（旧版） | 通则 | 通则 | 一般要求 | 一般要求 | 5.1 - 5.16 | 5.1 - 5.16 | 防止生产中的交叉污染 | 防止生产中的交叉污染 | 5.17 增加： - 除了第3章中所指的非药用产品的生产 - 禁止有毒物、杀虫剂和除草剂的生产和存贮 | 5.17 | 5.18 增加 - 基因产品、原料药或原料 - 删除了所提到的激素、细胞抑制类药物、高效物质 | 5.18 | 5.19 增加 - 通过设计来防止交叉污染，引用第3章 | 5.19 | 5.20（引用EMA关于共用设施的指南） | | 5.21 | - | 5.22 | 5.20 | 验证 | 验证 | 5.23 -5.26 | 5.21-5.24 | 原料 | 原料 | 5.27 增加 - 供应商确认 | 5.25, 5.26 | 5.2 增加 - 质量协议 - 删除了与供应商讨论质量标准 | 5.26 | 5.29 | - | 5.30 增加 - 测试文件记录 | 5.27 | 5.31 - 5.34 | 5.28 - 5.31 | 5.35 | - | 5.36 | - | 5.37 - 5.39 | 5.32 - 5.34 | 工艺步骤：中间体和散装货 | 工艺步骤：中间体和散装货 | 5.40 - 5.44 | 5.35 - 5.39 | 包材 | 包材 | 5.45 增加 - 内包和印刷包材供应商的选择、确认和支持 | 5.40 | 5.46 - 5.48 | 5.41 - 5.43 | 包装工艺 | 包装工艺 | 5.49 - 5.62 | 5.44 - 5.57 | 成品 | 成品 | 5.63 - 5.65 | 5.58 - 5.60 | 拒收、回收和退回物料 | 拒收、回收和退回物料 | 5.66 - 5.70 | 5.61 - 5.65 | 5.71 | - | | | |
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