Safety Systems Audit 良好操作规范（GMP）/食品安全审核 for:受审方 Report Date报告日期 Audit by审核员 Silliker, Inc This audit report sets forth Silliker, Inc. ("Silliker") findings as of the date herein. Silliker shall not assume any responsibility for the programs and/or facility being audited...
Pro QC Report Example – Audit Score and Summary Pro QC Report Example – Recommended Corrective Actions Applicable standard ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices, Section 4.7 Questionnaire item Is there adequate lighting, that is ...
“Our investigator also noted that your firm copied raw data to a CD and then deleted the data from the system to free space on the hard drive. Files copied to the CD were selected manually; the selection process was not supervised. Without audit trail capabilities or supervised file selectio...
(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. Conclusions 总结 A statement regarding the GMP...
Summary Service Type GMP Audit Checklist Provider Name NBScience, Area pharmaceuticals Description GMP Audit Checklist Categories: Stem Cells therapy Tags: GMP Audit Checklist NBScience contract research organization Search for: Search … Select language: More information: Stem cell therapy is one...
summary reports 远程审核报告摘要的局限性 Document retention 文件保存 Disposal of original records 原始记录的废弃 Specific data integrity considerations for computerised systems 计算机化系统特定数据完整性考虑 Structure of QMS and control of computerised systems QMS结果和计算机化系统的控制 Qualification and...
GMP变更评估 变更评估项目Assessment Item A 标准方法（原料，成品和包材）Specs Methods (Raw materials - Finished products - Packaging Materials)A.1 人员People A.1.1 实施培训Training A.2 文件Documents A.2.1 影响对规程/内控标准Impact on procedures /in-house specification A.2.2 新质量标准的合理性...
1、PIC/S 受法规约束的 GMP/GDP 环境下数据管理和完整 性优良规范(中英文) PIC/S GUIDANCE PIC/S 指南 PIC/S : 国际药品监查合作计划 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS 受法规约束的 GMP/GDP 环境下数据管理和完整性优良规范 PIC/S August 2016 2016 年 ...
–You should request summary sessions (daily wrap-up meetings) from the auditors at the end of each day’s activities to clarify any issues that may have been unclear during the audit. –Inform the auditor of any immediatecorrective actionscompleted and take the opportunity to discuss the next...
方接收测试(FAT) Issue Factory acceptance test 设计确认 (DQ) Issue DQ (Design qualification) 安装确认 (IQ) Issue IQ (installation qualification) 运行确认 (OQ) issue OQ (operation qualification) 性能确认(PQ) issue PQ (performance qualification) 确认总结报告(QSR) Issue Qualification Summary Report D...