指令应由申办人发给临床试验用药品的生产商。 7.8.The order should be in writing (e.g.by paper or electronic means), be authorized and contain sufficient detailincluding the approved product specification file (see below) and the relevantclinical trial protocol, as appropriate, to avoid any ambiguit...
7.8. The order should be in writing (e.g. by paper or electronic means), be authorized and contain sufficient detail including the approved product specification file (see below) and the relevant clinical trial protocol, as appropriate, to avoid any ambiguity. 订单应为书面形式(例如,通过纸质或...
指令应由申办人发给临床试验用药品的生产商。 7.8. The order should be in writing (e.g.by paper or electronic means), be authorized and contain sufficient detailincluding the approved product specification file (see below) and the relevantclinical trial protocol, as appropriate, to avoid any ambigu...
指令应由申办人发给临床试验用药品的生产商。 7.8. The order should be in writing (e.g.by paper or electronic means), be authorized and contain sufficient detailincluding the approved product specification file (see below) and the relevantclinical trial protocol, as appropriate, to avoid any ambigu...
7.8. The order should be in writing (e.g.by paper or electronic means), be authorized and contain sufficient detailincluding the approved product specification file (see below) and the relevantclinical trial protocol, as appropri...
7.8.The order should be in writing (e.g.by paper or electronic means), be authorized and contain sufficient detailincluding the approved product specification file (see below) and the relevantclinical trial protocol, as appropriate, to avoid any ambiguity. ...
Audit Report Grading and Audit Frequency forFunctional Food Facilities was updated to add the new grading table for theChina GMP for Nutritional Supplements Audit. 更新了功能性食品设施的审核报告分级和审核频率,为中国营养补充剂GMP审核增加了新的分级表。
The audit report is reviewed for the purpose of closing N.C.(Non-conformance) and making a referral to the next stage of auditing, which is Stage 2. System and Process Audits in accordance with the requirements of the standard constitute Stage II of the audit (s). It is required for th...
–中国GMP的要求：第76条的要求，质量管理部门应会同有关部门对主要物料供应商质量体系进行评估，ChineseGMP,ITEM76:Qualitydepartmenthastheresponsibilitytoperformtheaudittoassesthequalitysystemofthemainvendorwithrelateddepartments –WHOGMP第8.8条：质量管理负责人有义务协同其他部门批准能提供符合要求的起始原料和包装...
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 ...