10.4 The inspection report format should be incompliance w ith the European model.检验报告格式应符合欧洲模板要求。 10.5 The report should be sent to the responsibleperson o f the inspected structure (preferably the qualified perso...
10.4 The inspection report format should be incompliance w ith the European model.检验报告格式应符合欧洲模板要求。 10.5 The report should be sent to the responsibleperson o f the inspected structure (preferably the qualified person). The leadinspector and all concerned inspectors should participate i...
26、label[ˈlebəl]vt.标注;贴标签于;n.标签;商标;签条Labelsappliedtocontainers,equipmentorpremisesshouldbeclear,unambiguousandinthecompany’sagreedformat.(欧盟GMP5.13)容器、设备或设施所用标记应清晰明了,其格式应通过公司的同意。unlabeled未贴标签的cut-label可切割式标签mislabeling贴错标签的approved...
The audit report should address general GMP requirements, as for example the quality management system, all relevant production and quality control procedures related to the supplied product, e.g. active substance manufacturing, quality control testing,? \o 分类:内包装 primary packaging, etc. All ...
These arran geme nts en sure that data, irrespective of the process, format or tech no logy in which it is gen erated, recorded, processed, reta in ed, retrieved and used will en sure a complete, con siste nt and accurate record throughout the data lifecycle. 数据管理是为数据完整性...
Operational:all equipment is installed and is functioning to an agreed format and a specified number of personnel are present, working to an agreed procedure. The airborne particle count test is performed by counting particles at defined grid locations within the cleanroom. The t...
do not differ depending on the data format; paper-based and electronic data record-keeping systems are subject to the same requirements. 作为CGMP记录的一部分所创建的任何数据必须作为放行标准的一部分由质量部门评估(见§§211.22和212.70),并予以保存以符合CGMP(例如,§ 211.180)。为满足CGMP要求产生的电子...
Pharmaceutical Deviation Report System This SOP categorizes deviations between production, audit, quality improvements, and EHS deviations. It describes the management responsibilities of initiating deviations, analyzing them, investigating them, determining assignable causes, and taking corrective and preventative...
Since most of the EU authorities and all MRA partners are member of PIC/S, synergies between the various audit schemes are used in order to avoid duplication. BEMA Audits The Benchmarking of European Medicines Agencies (BEMA) is an internal EU program managed by the Heads of Medicines ...
do not differ depending on the data format; paper-based and electronic data record-keeping systems are subject to the same requirements. 作为CGMP记录的一部分所创建的任何数据必须作为放行标准的一部分由质量部门评估(见§§211.22和212.70),并予以保存以符合CGMP(例如,§ 211.180)。为满足CGMP要求产生的电子...