ICH-Q7(中英文对照)Q7a(中英文对照) FDA原料药GMP指南 Table of Contents 1. INTRODUCTION 1. 简介 Objective 目的 Regulatory Applicability 法规的适用性 Scope 范围 2. QUALITY MANAGEMENT 2.质量管理 Principles 总则 Responsibilities of the Quality Unit(s) 质量部门的责任 Responsibility for Production ...
2.20 The quality unit(s) should be involved in all quality-related matters. 2.20 质量部门应当参与所有与质量有关的事物。 2.21 The quality unit(s) should review and approve all appropriate quality-related documents. 2.21 所有与质量有关的文件应当由质量部门审核批准。 2.22 The main responsibilities of...
Section 2.2 (1.)stipulates that the quality unit is responsible for releasing or rejecting allAPIs and intermediates foruse outside of the manufacturing company and that theseresponsibilities shouldnot be delegated. The reason for this is that these decisions by the Q.C. unit should not bequestio...
11. Q. Does the quality section need to signoff/approve the validation reports in addition to validation protocols? 问:质量部门是不是在验证方案之外还必须签名或是批准验证报告? Yes. This is discussed in Section 2.2, item 10. The Quality Unit's responsibilities shouldinclude "Reviewing and approvi...
QUALITY MANAGEMENT 2. 质量管理 2.1 Principles 1 2.1 总则 2.2 Responsibilities of the Quality Unit(s) 2 2.2 质量部门的责 任 2.3 Responsibility for Production Activities 3 2.3 生产作业的职责 2.4 Internal Audits (Self Inspection) 4 2.4 内部审计(自检) 2.5 Product Quality Review 5 2.5 产品质量审核...
Q7a(中英文对照) FDA原料药GMP指南 TableofContents 目录 1.INTRODUCTION 1.简介 1.1Objective 1.1目的 1.2RegulatoryApplicability 1.2法规的适用性 1.3Scope 1.3范围 2.QUALITYMANAGEMENT 2.质量管理 2.1Principles 2.1总则 2.2ResponsibilitiesoftheQualityUnit(s) 2.2质量部门的责任 2.3ResponsibilityforProductionActivities ...
QUALITY MANAGEMENT2.质量管理2.1 Principles2.1总则2.2 Responsibilities of the Quality Unit(s)2.2质量部门的责任2.3 Responsibility for Production Activities2.3生产作业的职责2.4 Internal Audit 2、s (Self Inspection)2.4内部审计(自检)2.5 Product Quality Review2.5产品质量审核3. PERSONNEL3. 人员3.1 Personnel ...
2. QUALITY MANAGEMENT Principles 总则 Responsibilities of the Quality Unit(s) 质量部门的责任 Responsibility for Production Activities 生产的职责 Internal Audits (Self Inspection) 内部审计(自检) 2 ichq7(中英文) 来自淘豆网www.taodocs.com转载请标明出处. ...
2. QUALITY MANAGEMENT2.质量管理 2.1 Principles2.1总则 2.2 Responsibilities of the Quality Unit(s)2.2质量部门的责任 2.3 Responsibility for Production Activities2.3生产的职责 2.4 Internal Audits (Self Inspection)2.4内部审计(自检) 2.5 Product Quality Review2.5产品质量回顾 3. PERSONNEL3.人员 3.1 Personnel...
The person in the quality unit who is responsible for final decision-making (e.g., batch release decision) should not have responsibilities for production activities [ICH Q7, Section 2.13]. “质量部门独立于生产”是 什么意思? “独立”一词意在防止利益冲突,保证对与质量相关的决定能在 组织结构内...