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(转自GMP论坛)
Major developments and Good Manufacturing Practices - Major developments 药品生产质量管理规范-重大进展 17/01/2012 2012年1月17日 Revision of EU Commission guidelines on Good manufacturing Practice Medicinal Products 欧盟委员会修订药品生产质量管理规范指南 Today, the European Commission launches the public consultation of the following revised guidelines on good manufacturing practices: 今天，欧盟委员会启动对下列修订的药品生产质量管理规范指南进行公开咨询： Chapter 3: Premises and Equipment(53 KB) 第3章：房屋与设备(53 KB) Reasons for changes: 变动的原因： The only change is to section 6 as part of the improved guidance on prevention of cross-contamination involving also Chapter 5 and includes reference to a new complementary toxicological assessment guidance. 仅仅变更了第6节作为同样在第5章所涉及到的预防交叉污染指南部分的改进，并包括参考一个新的补充性毒理学评价指南。 Chapter 5: Production(84 KB) 第5章：生产(84 KB) Reasons for changes: 变更原因： Changes have been made to sections 17 to 20 to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment guidance. Changes were also introduced in sections 26 to 28 on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Section (33) is inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials while section (68) introduces guidance on notification of restrictions in supply. 已经对第17至20节做出了变更来改进预防交叉污染的指南，并参阅毒理学评价指南。同样也对第26至第28 节的供应企业资质进行了变更，来反映制造许可持有人的法律义务，以确保原料药按照药品生产质量管理规范进行生产。这些变更包括供应链可追溯性。增加了第33节被，来澄清与协调有关对起始物料测试期望，而第68节介绍了在限制供应指南。 Chapter 6: Quality Control(63 KB) 第6章：质量控制(63 KB) Reasons for changes: 变更原因： Inclusion of a new section on Technical transfer of testing methods and other items such as out of specification results. 增加了新章节，关于测试方法以及其它项目，如，超标数据结果，的技术转移。 Chapter 8: Complaints, Quality Defects and Product Recalls(79 KB) 第8章：投诉、质量缺陷和产品召回(79 KB) Reasons for changes: 变更原因： - To reflect Quality Risk Management principles to be applied when investigating quality defects/complaints and when making decisions in relation to product recalls or other risk-mitigating actions. - 反映应用于质量缺陷/投诉调查以及在作出有关产品召回或其它风险减缓措施中的质量风险管理基本原则。 - To emphasise the need for the cause(s) of quality defects/complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue. - 强调对需要调查与判断的质量缺陷/投诉原因，以及有适当的预防性措施来防止问题的复发。 - To clarify expectations and responsibilities in relation to the reporting of quality defects to the Supervisory Authority. - 澄清关于向监督官方报告质量缺陷的期望与责任。 Chapter 3 and 5 should be read in conjunction with the draft EMA guideline (170 KB)on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities 第3章与第5章应当与欧洲药品管理局指南(170 KB)一道阅读用辨识共享设施制造不同药品的风险来设立基于健康的暴露限度。
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发表于 2013-1-19 10:02:48
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