- 1、本文档共76页,可阅读全部内容。
- 2、原创力文档(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
- 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
APIC清洗验证指导概要1
20140716 ECA新闻:FDA警告信中最常见GMP违规情况??
Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters
FDA警告信中最常见GMP违规情况失效调查、供应商确认和稳定性试验不充分
The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient?investigation of unexplained discrepancies and?deviations from?defined standards and specifications in their inspections. The corresponding paragraph?21 CFR 211.192?requires that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments understanding of deviations handling,?failure investigations?and corrective actions is frequently fragmentary.
对2013财年的警告信分析结果显示,最近几年FDA在其检查中,发现对未解释的不符合既定标准和规格的情况及偏差调查不充分。21 CFR 211.192对应的段落要求制药公司说明偏差的原因,采取纠正措施,同时建立完整的文件记录。在过去5年中,每年平均有约22封警告信中列有该缺陷,说明许多公司的质量保证部门对偏差处理、失效调查和纠正措施的理解是不完整的。
Quite interesting is the detailed study of the warning letters referring to GMP violations with regard to 211.192. These warning letters take into account the drugs dosage forms. In particular manufacturers of oral dosage forms were addressees of?warning letters?containing citations with regard to 211.192, followed by parenteral drugs manufacturers, companies in the area of blood/blood products and manufacturers of topical drugs. The respective scenarios are quite different. However, main shortcoming is always the inadequate education and documentation in each incident.
对警告信中与211.192相关的GMP违规情况研究很有意思。从警告信涉及的药品剂型来看,口服剂型生产商首当其冲,其次是注射剂型生产商,以及血液及血液制品和局部用药产品生产商。当然,主要缺点永远都是对每次事件的教育和记录不充分。
A rather unexpected finding in the lineup of the most common GMP violations is the high number of citations with regard to21 CFR 211.84?Testing and approval or rejection of comp
您可能关注的文档
- Anne of The green gables清秀佳人大学生小剧本同步演示概要1.pptx
- ANSA14.0培训教程概要1.ppt
- Another door概要1.ppt
- 农业区位因素与农业地域类型概要1.ppt
- 文化生活_选择题01概要1.doc
- answers to unit 4概要1.ppt
- ansys CFD全套基础教程016F1EditMeshV10中文概要1.ppt
- 整合的圣诞节概要1.ppt
- Another door 另一扇门概要1.ppt
- ansys CFD全套基础教程016F2WSWingBody1V10中文概要1.ppt
- 第十一章 电流和电路专题特训二 实物图与电路图的互画 教学设计 2024-2025学年鲁科版物理九年级上册.docx
- 人教版七年级上册信息技术6.3加工音频素材 教学设计.docx
- 5.1自然地理环境的整体性 说课教案 (1).docx
- 4.1 夯实法治基础 教学设计-2023-2024学年统编版九年级道德与法治上册.docx
- 3.1 光的色彩 颜色 电子教案 2023-2024学年苏科版为了八年级上学期.docx
- 小学体育与健康 四年级下册健康教育 教案.docx
- 2024-2025学年初中数学九年级下册北京课改版(2024)教学设计合集.docx
- 2024-2025学年初中科学七年级下册浙教版(2024)教学设计合集.docx
- 2024-2025学年小学信息技术(信息科技)六年级下册浙摄影版(2013)教学设计合集.docx
- 2024-2025学年小学美术二年级下册人美版(常锐伦、欧京海)教学设计合集.docx
文档评论(0)