04-Basic GMP Audit Check List BASICGMP(GOODMANUFACTURINGPRACTICES)AUDITCHECKLIST 1.FACILITIESANDEQUIPMENT厂房/设备 BASICGMPREQUIREMENT/CRITERIAGMP要求/标准 1.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).Isthe facilityclean(internal/external)?Throughoutthe...
systematic and consistent audit.A checklist, however, should not be a substitute for proper planning and cooperative climate-setting prior to starting the audit. Consider the advantages of using a well-prepared checklist. It ensures that the auditor will ask most of the critical items necessary to...
Therefore, the author accepts no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist. Instructions for Using this Audit Checklist: Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem ...
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1、EU cGMP AUDIT CHECKLISTDATE: _CLIENT NAME:_AUDITORS:_ SIT E AD D R E SS:_TY PE o f A CT IVIT Y (cG MP or PA I: _ 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自然。 知识如氧气无处不在,沟通如呼吸轻松自...
PIC/S审计清单(Audit Checklist)是PIC/S对药品监管机构进行GMP监管体系评估的指标体系,该指标体系共有11个模块,细分为38项亚指标[3],其中模块5检查程序包含6项亚指标,围绕实施检查的过程展开评估,包括检查策略、检查前准备、检查报告格式和内容、...
PIC/S审计清单(Audit Checklist)是PIC/S对药品监管机构进行GMP监管体系评估的指标体系,该指标体系共有11个模块,细分为38项亚指标[3],其中模块5检查程序包含6项亚指标,围绕实施检查的过程展开评估,包括检查策略、检查前准备、检查报告格式和内容、执行检查的SOP(检查方法学)、检查后活动、检查数据存储等。PIC/S按照...
EU cGMP Audit Checklist the authorisation of written procedures and other documents, including amendments; the monitoring and control of the manufacturing environment; plant hygiene; process validation; training; the approval and monitoring of suppliers of materials; the approval and monitoring of contract...
GMPCheckListGMP检验单QARepresentative:Date:质管日期Lot#Checked:Cell:批号单位⑴GeneralWorkAreaAudit一般工作区域的审核PF1Nofoodordrinkinrestrictedareas.□口指定区域内严禁食物和饮料2Theworkareaappearscleanandorderly.□口工作区域干净整洁3Materialincelliswithinappropriately5-pillar(tapedoff)zonesanddonot口口exceed...
GMP现场检查Checklist(ENGLISH).doc,6.2 Addendum B:GMP Checklist for Compliance with GMP DIRECTORATE: INSPECTORATE and LAW ENFORCEMENT INSPECTOR’S CHECKLIST FOR ROUTINE GMP INSPECTION 6.3 Addendum C: Cover letter for GMP inspections SUB DIRECTORATE: MEDI