实验室管控体系.pptVIP

LABORATORY CONTROL SYSTEM 实验室控制体系 December 2005 CGMP GENERAL REQUIREMENT  FOR LABORATORY CONTROLS 针对实验室控制，CGMP总体要求 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. 实验室控制应该包括建立科学合理的规范，标准，取样方案，确保所有部件，药品容器，盖子，在制材料，标签和药品符合适当的特性，质量，纯度标准 CGMP GENERAL REQUIREMENT  FOR LABORATORY CONTROLS实验室控制CGMP总要求 21 CFR 211.160 (b) (1) Laboratory controls shall include实验室控制应该包括 Determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products …………….…. 适当的书面规范对于每一批在装运的部件验收，药品器，盖子，和在药品制造，加工，包装，存放的标签应该一致。 CGMP GENERAL REQUIREMENT  FOR LABORATORY CONTROLS实验室控制CGMP总要求 21 CFR 211.160 (b) (2) Laboratory controls shall include实验室应该包括 Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. 取样程序的书面描述和在制材料的测试程序应该一致。像这样的样件应该具有代表性和可辨性 CGMP GENERAL REQUIREMENT  FOR LABORATORY CONTROLS实验室控制CGMP总要求 21 CFR 211.160 (b) (3) Laboratory controls shall include实验室控制应该包括 Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. Such samples shall be representative and properly identified. 取样程序的书面描述和药品合适的规格应该一致。像这样的样件应该具有代表性和可辨性。 LABORATORY CONTROLS (Q7A)实验室控制 11.1 General Controls总控制 ……There should be documented procedures describing sampling, testing, approval, or rejection of materials and recording and storage of laboratory data……