2014版-gmp验厂审核检查表.docx

Retail Factory Audit ReportNon-Regulated Basic GMPQT Report:Audit Dates:审核日期Report Date:报告日期Audit Owner:Audit ActiFactory Name:工厂名字Lead Auditor:审核组长Address:地址Auditor(s):审核员FailPass With ConditionsPass#Major CAPAs:All program requirements for?certificate met??(RCP Cert Committee only)#Minor CAPAs:Noncompliant不符合Marginal警戒Compliant符合CAPA follow-up required?NOYESNOT RCPFactory Grade:工厂等级Factory Score:得分0.00%YES??NO ?Scope of audit:Products:Most recent audit date:What entity performed the audit?Audit result:Types of certifications maintained:FDA Registration Type and Number:Company Representative during audit:Production Area- Ft?2?:# production lines:Packaging Area- Ft?2?:# Packaging lines:Warehouse - Ft?2?:Total Plant Size- Ft?2?:COMPLETE SECTION BELOW FOR CAPA FOLLOW-UP ONLYQT Report:Audit Dates:Report Date:FailPass With ConditionsPass#Major CAPAs:#Minor CAPAsRe-Audit required?All program requirements for certificate met? (RCP Cert Committee only)NO YES?NOT RCPNoncompliantMarginalCompliantFactory Grade:Factory Score:0.00%YES?? NO ?#BASIC GMP REQUIREMENT / CRITERIA / REFERENCEGMP 要求/标准/参考Total PossibleScore最高可能得分Points Scored实际得分Yes/ No是/否Major or minor主要/轻微Facilities and Equipment厂房/设备FE1Is the facility clean (internal/external)?Throughout the course of the assessment, observation of cleanliness should be taken. Cleanliness should be defined as an environment that reduces and/or eliminates the potential for contamination.工厂是否干净（评估的整个过程都要观察工厂清洁情况，工厂应该有定义清洁的环境要素并持续改善清洁状况）200FE2Are there written procedures addressing the maintenance of the?facility??Preventive Maintenance policies and schedules should be documented. Records should be available for review and should contain information regarding daily pre-operation equipment inspection, daily monitoring of equipment function, daily housekeeping activities, sanitation activities and any other necessary activities to maintain the safety and quality of product.有没有书面的厂房/设施维护程序？预防性维护的政策和程序。每日开机检查记录，每日设备功能检查记录，每日打扫卫生记录，以及其他所需的工