基于USP的称量管理.pptxVIP

基于USP的称量管理第1页/共58页第2页/共58页Warning Letters2015中国警告信欧盟：6家FDA ：2家 (2014年6家）加拿大：5家FDA对印度：9家To: /ICECI/EnforcementActions/WarningLetters/2015/ucm478393.htmSun /ICECI/EnforcementActions/WarningLetters/2015/ucm478393.htmPharmaceutical Industries Ltd.Your firm failed?to routinely calibrate, inspect, or check according to a written program designed to assure proper performance?and?to maintain adequate written records of calibration checks and inspections of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product。?第3页/共58页FDA对大连辉瑞发出的483表1、?QC实验室的色谱数据工作完全偏离QC实验室书面所述的流程2、?遇到有问题的样品数据，实验室没有按照SOP-56980规则重新测试并作出结果说明3、?多篇数据报告结果相同，分析结果与后续的分析报告数据不一样无后续跟踪4、?批量生产和控制记录时间日期和填写内容不匹配5、?检查发现质检员工有参与数据记录修改重新填写现象6、?设备的使用登记记录问题7、?不配合掩饰阻碍检查8、?生物实验室记录未及时填写9、?卫生设施和报废设备安置点问题第4页/共58页和校准相关的警告信Deltex Pharmaceuticals Inc 31-Oct-08Failure to follow written procedures applicable to the quality control unit and to establish adequate procedures in writing as required by 21 CFR § 211.22(d). Specifically, your SOP # QC-016-0 requires that the Quality Control Manager or designee calibrate the?[(b)(4)]?FT-IR spectrometer with an internal reference standard on a?[(b)(4)]?basis. This was not done for six months following the last calibration on November 9, 2007. In addition, your SOP # QC-012-1, requiring the Quality Control Manager to ensure that in-house calibration of all scales and balances is performed ?[(b)(4)]?with?[(b)(4)]?standard weights, was not followed. Calibrations of the?[(b)(4)]?Scale used to weigh active ingredients were performed with only?[(b)(4)]?weights for a period of 11 months (February 2007 to January 2008第5页/共58页和校准相关的警告信Abba Pharma Inc. 2/9/11?Your firm failed to establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a).?Further, your firm failed to make and keep documen