In order to ensure the quality and safety of our products, we have conducted a self-inspection based on Good Manufacturing Practice (GMP) guidelines. This report aims to provide an overview of our findings and the actions taken to address any identified issues. 中文回答: 自我介绍: 为了确保产品...
MHRA第三国GMP检查 Workshop on GMP/Pharmacopoeia/APIs
几年前,GMP的主要违规情况也在欧洲检查数据库中开始发布。英国药监(MHRA)则采用了更为详细的方法。请看以下自2015年以来MHRA发布的在验证/确认主题上的例子: In the top 10 of MHRA's inspection deficiencies 2015, the topic validation occupies rank 8. However, no critical deficiency was found. Most 'maj...
Inspection findings from 2012 show CGMP deficiencies in the following major areas: The quality unit does not function as the CGMP regulations require: Approving or rejecting procedures, major decisions about quality including batch release (21 CFR 211.22). Production and process controls are not ...
Reporting checklist findings at an enterprise-wide level can be filtered to your needs by options such as inspection type, users, site, region, question, or answer.Within your configurable dashboard, you can track issues identified, set up automated notifications and actions, and so much more. ...
PIC/S GMP缺陷分级指南 PI 040-1 3 Appendices 1 January 2019 1. DOCUMENT HISTORY 文件历史 Ado...
To achieve and maintain mutual recognition ofinspection findings in the Union and facilitate the cooperation of the MemberStates, commonly recognised standards on the conduct of inspections on goodmanufacturing practice for investigational medicinal products in the form ofprocedures should be developed. The...
篇一:新版 GMP 整改报告 doc 制药有限公司 药品 GMP 认证现场检查不合格项目整改报告 国家食品药品监督管理局药品认证管理中心: 针对 2022 年 4 月20 日至 24 日国家食品药品监督管理局药品 GMP 认证检查组 对我公司大容量注射剂、小容量注射剂、冻干粉针剂进行现场检查提出的 14 项 普通缺陷项目, 我公司在第...
The article focuses on the comparison of the top 10 good manufacturing practices (GMP) cited by Pharmaceutical Inspection Cooperation Scheme (PIC/S) members, which were discussed at a PIC/S workshop in November 2011. The workshop involved a survey of GMP inspection findings of finished product ...
(d) Frequency of self-inspection. 自检频率 (e) Self-inspection report. 自检报告 (f) Follow-up action. 后续行动 (g) Quality audit. 质量审计 (h) Suppliers’ audits. 供应商审计 F. Summary 汇总 Brief summary of thefindings, and recommendations (whereapplicable). 简要汇总发现的问题和建议 G. ...