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...
Audit Checklist 1 Question Instructions/Questions Note any exceptions and comments in notebook Yes/No/NA 1.0 General Controls Does the facility and its many departments (organizational units) operate in a state of control as defined by the GMP regulations? 1.1 Organizational & Management Responsibi...
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Many auditors prefer to use a notebook for a single audit so it may be filed with the checklist and the final report. The references to sections in the GMP regulation are for your convenience should a question arise. In some instances, two or more sections within the GMP regulation may ...
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
Prepare a checklist of the items to be audited based on cGMP’s, area procedures, etc. 1.3.4审计前,检查上一次审计的结果状态,以找出任何未完成的整改。 Before the audit, verify status of previous audits to address any open action 1.3.5执行审计,并将任何潜在的缺陷告知责任部门的管理人员。 Execut...
In addition, a comprehensive checklist for GMP audits can be used as a tool, guiding auditors through a detailed review of all relevant aspects of production, from raw material sourcing to the final product release. The GMP audit report serves as a critical document, detailing compliance with ...
report, • 批准,approve, 2021-1-9 整理ppt 17 供应商审计vendor audit • 审计供应商的质量管理体系是否有效地工作,Audit supplier quality management system to work effectively, • 评估供应商各分体系是否处于受控状态,Evaluating vendor sub-system in a controlled state, • 评估供应商是否能持久地...
This GMP checklist is based on regulatory requirements and personal experiences. I. 组织和人员 Organization and Personnel A.质量部门责任 Responsibilities of the Quality Unit (QU) 企业应当建立独立的质量部门,质量部门应当参与所有与质量有关的活动 There should be a QU that is independent of production....
Costco GMP审核事项和审核标准20200327 COSTCO NONFOOD GMP AUDIT SUPPLIER SEMINAR 2020 供应商研讨会 Prepared by Iris Liu Mar. 27, 2020