CGMP_LABORATORY_CONTROL_2016_CHN.pdfVIP

LABORATORY CONTROLS 实验室控制体系 CGMP Regulation for Laboratory Controls 实验室控制 21 CFR 211.160 b Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in- process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. 实验室控制包括建立有科学性的适当的质量标准，标准品，样品 计划，分析方法，用以保证药物成分，包装，中间体，标签及成 品能满足适当的身份，强度，质量和纯度的标准 Laboratory Controls 实验室控制体系 2 Laboratory Controls ICH Q7A 实验室控制 11.1 General Controls ……There should be documented procedures describing sampling, testing, approval, or rejection of materials and recording and storage of laboratory data…… 要有文件（SOP ）规定取样，测试，批准或拒绝，记录和保存实验 室数据 ……All specifications, sampling plans, and test procedures should be scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labels and packaging materials conform to established standards of quality and/or purity……. 质量标准，样品计划和分析方法要有科学性，适用于保证原料，中 间体，原料药，标签及包装能满足质量标准和纯度 Laboratory Controls 实验室控制体系 3 Laboratory Controls 实验室控制 ICH Q10, Pharmaceutical Quality System Independent Quality Unit 独立的质量部门 Responsibilities In-house and outsourced manufacturing 内部及对外的职责 QC and QA Investigation of Atypical and OOS events 误差调查 Corrective Action and Preventative Action CAPA 改正和防范 Change management 变更控制 Management review of product and process quality 产品和工艺质量的管理评估 Laboratory Controls 实验室控制体系 4 Laboratory Controls 实验室控制 Establishment of Testing for 测试 建立 Components 原材料 Sampling Plans样品 计划 In-process Materials 中间体 Specifications质量 Final Products 产品 标准 Containers and Closures 包 Standards标准品 装 Test Procedures 分 析方法 Drug products DS DP 原 料药和制剂 Laboratory Controls 实验室控制体系 5 Documentation 文件 If you do not document it, you have not done it. 没有记录就是没有做 Raw data entry 原始数据 Traceability 追踪性 Correction 更改 Taped-in data/diagrams 附件 Data invalidation 无效数据