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Data Integrity and Compliance With Drug CGMP Questionsand Answers Guidance for Industry 行业指南:数据完整性与药品CGMP合规问答
I. INTRODUCTION前言 II. BACKGROUND 背景 III. QUESTIONS AND ANSWERS 问答 1. Please clarify the following terms as they relateto CGMP records:请澄清以下术语在用于CGMP记录时的含义 2. When is it permissible to invalidate a CGMP result and excludeit from the determination ofbatch conformance?什么时候允许宣布一个CGMP结果无效并在判定批合格时排除该结果? 3. Does each CGMP workflow on a computer systemneed to bevalidated?是否需要对计算机系统中的每个CGMP工作流均进行验证? 4. How should access to CGMP computer systems be restricted?应如何限制对CGMP计算机系统的访问? 5. Why is FDA concerned with the use of shared loginaccounts for computer systems?为什么FDA会关切使用共用计算机系统登录账号? 6. How should blank forms becontrolled? 空白表格要如何受控? 7. Who should review audit trails?审计追踪应由谁审核? 8. How often should audit trailsbe reviewed?审计追踪应多久审核一次? 9. Can electroniccopies be used as accurate reproductions of paper or electronicrecords?电子副本是否可用作电子或纸质记录的准确复制本? 10. Is it acceptable to retain paper printouts or static recordsinstead of original electronic recordsfrom stand-alone computerized laboratory instruments, such as an FT-IR instrument?是否可以将单机版计算机化实验室仪器,如FT-IR仪器中的原始电子记录保存为纸质打印件或静态记录? 11. Can electronic signatures be used instead of handwritten signatures for master productionand control records?主生产和检验记录中是否可使用电子签名替代手动签名? 12. When does electronic data become a CGMP record?电子数据何时成为一份CGMP记录? 13. Why has FDA cited use of actual samples during “system suitability” or test, prep,orequilibration runs in warning letters?为什么FDA在警告信中将“系统适用性”或检测、准备或系统平衡运行中使用实际样品作为缺陷? 14. Is it acceptable to only save the final resultsfrom reprocessed laboratory chromatography?是否可以只保存重新处理后的实验室色谱图得到的最终结果? 15. Can an internal tip or information regarding a quality issue, such as potential data falsification,be handled informally outside of the documented CGMP quality system?是否可以在书面CGMP质量体系以外以非正式方式处理内部提醒或关于质量问题的信息,如潜在数据造假问题? 16. Should personnel be trained inpreventing anddetecting data integrity issuesas partofa routine CGMP training program?是否要将防止和发现数据完整性问题培训作为常规CGMP培训计划的一部分? 17. Is FDA allowed tolook at electronic records?是否应允许FDA查看电子记录? 18. How does FDA recommend data integrity problems be addressed? FDA建议如何解决数据完整性问题?
官方英文原文下载 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf?utm_campaign=FDA%20finalizes%20guidance%20on%20Data%20Integrity%20and%20Compliance%20with%20Drug%20CGMP%3A%20Questions%20and%20Answers&utm_medium=email&utm_source=Eloqua
本文摘自 Julia法规翻译
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