证书申请递交的质量综述模板 qos.docVIP

ICEP/29 Template for Quality Overall Summary to be submitted for Certification applications 证书申请递交的质量综述模板 NB?: Reference?: PA/PH/CEP (04) 1 (as revised) Content of the dossier for chemical purity and microbiological quality (can be downloaded from EDQM website HYPERLINK http://www.edqm.eu http://www.edqm.eu) quality overall summary 质量综述 Substance name产品名称 Monograph n°个论号 Subtitle (if any) 副标题（如果有的话） Intended Holder of the CEP CEP证书持有人 Written by 撰写人 Qualification*资质 Date日期 (*)?: append CV of the expertquality overall summary 2.3.S DRUG SUBSTANCE原料药 2.3.S.1 General Information一般信息 Use of the substance?:Route(s) of administration, maximum daily dose. 用途：（给药途径，每日最大剂量） Commercialisation history: Summarise the history based on the table in application form). 贸易历史：（按申请表中的概述） Declarations: Summarise the declarations appended to the application form: 声明：（概述附于申请表后的声明） - Manufacture of the substance in accordance with ICH Q7A GMP rules 该原料药生产遵循了ICH Q7A GMP法规条款 - Commitment by the manufacturer to keep the proposed holder informed of any changes to the documentation. 生产商的承诺：任何文件变更都会及时通知持有人 - if applicable?: Manufacturers authorisation for X to act as representative 生产商对某人作为代表人的授权书（如果有的话） - Willingness to be inspected (holder, manufacturers) 愿意接受现场检查（持有人，生产商） - Non-use/use of materials of human or animal origin in the process 生产过程中未使用/使用了来源于人或动物的物料 2.3.S.1.1 Nomenclature 命名 (a) Recommended International Non-proprietary name (INN):国际非专有名称 (b) Chemical name(s):化学名 (c) Company or laboratory code:公司或实验室编码 (d) Other non-proprietary name(s) (e.g., national name, USAN, BAN):其他非专利名称（如，国家命名，美国采用名，英国认可名） (e) CAS No. Molecular Formula分子式 MW: 分子量 2.3.S.1.3 General Properties特性 Give summarised data on:提供以下信息 (a) Physical description (e.g., appearance, colour, physical state…) 形状描述（如：外观、颜色、物理状态） (b) Physical form (e.g., polymorphic form, solvate, hydrate): to be commented especially if requested as grade. 物理形态（如：多晶型，溶剂化物，水合物）：按要求分级别作出描述 (c) Solubility and other properties as