APIC颁布原料药工厂清洁验证指南说课材料.docxVIP

APIC颁布原料药工厂清洁验证指南 精品文档 精品文档 收集于网络，如有侵权请联系管理员删除 收集于网络，如有侵权请联系管理员删除 精品文档 收集于网络，如有侵权请联系管理员删除 APIC颁布原料药工厂清洁验证指南 An APIC multinational working group has compiled a new guidance on cleaning validation with the title APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants. Publication date is May 2014 and the document can be downloaded from the APIC website. The following is a summary description of the document. The document contains 55 pages and is subdivided into 13 chapters. APIC多国工作组汇编了新的清洁验证指南，题为“APIC原料药工厂清洁验证指南面面观”。颁布日期为2014年5月，文件可以从APIC官网下载。以下是该文件的摘要。文件包括55页，分为13章。 Foreword 前言 Objective 目的 Scope 范围 Acceptance Criteria 可接受标准 Levels of Cleaning 清洁水平 Control of Cleaning Process 清洁工艺控制 Bracketing and Worst Case Rating 括号法和最差情况分类法 Determination of the Amount of Residue 残留量的检测 Cleaning Validation Protocol 清洁验证方案 Validation Questions 验证问题 References 参考文献 Glossary 术语 Copyright and Disclaimer 版权和声明 The topic cleaning validation gained new importance in the EU with the publication of the EMA Guideline Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities and with the chapter Cleaning Validation in the draft of the revision of Annex 15. The foreword refers to the integration of cleaning validation within a quality system supported by quality risk management processes in order to protect the patients. According to the authors the document is aligned with ISPE Risk-MaPP and it recommends the revised PDA Technical Report 29 as a valuable guidance document. The document is supposed to assist companies in cleaning validation and to serve as a starting point for internal discussions. It should in no way be considered as a technical standard. The document addresses six topics: 清洁验证主题在欧盟EMA指南 前言指出了清洁验证应与质量体系结合，由质量风险管理过程支持，以保护患者利益。根据文件作者们所言，该文件与ISPE的药品风险管理是一致的，并推荐将修订后的PDA第29号技术报告作为参考文件。该文件意在清洁验证方面给公司提供帮助，作为内部讨论的基础，而不应作为一个技术标准。文件阐述了以下6个主题： Acceptanc