编写site master file的指导程序
SITE_MASTER使用指南[1]
![SITE_MASTER使用指南[1]](https://img.taocdn.com/s3/m/2c0968c789eb172ded63b721.png)
*7、按F2软键选终止频率
*8、输入数字2000，然后按ENTER设置F2为2000MHZ
作校准
广东省长讯实业公司
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*9、按START CAL键，照文字的提示操作 *10、将OPEN连到REFL口，按ENTER，待仪表测试完成
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*11、出现提示后断开OPEN，连接SHORT端子到REFL口，然后 按ENTER键，待仪表测试完成
Open---开路器 Short---短路器 Load---负载器
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-将测试口扩充电缆（ the test port extension cable）连到测试端口。
- 按 START CAL 键。 - 连接标记为“OPEN”端 的Open/Short器到测试扩充电缆的末端，然后按 ENTER。
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表二、天线安装测试所需的部件
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四、驻波比（SWR）测试
步骤： 1. 按 OPT 软键（在主菜单中）。 2. 按B1软键选定 MODE = SWR。 3. 按 MORE软键。 4. 再按 MAIN 软键。 5. 检查所有的连接点是否正确且拧紧。 6. 按 FREQ 软键。 7. 检查所选的频率范围是否正确。 8. 按 MAIN 软键。 9. 按 SCALE 键。 10. 按 TOP 软键。 11. 输入1.5 的顶部刻度值，然后按ENTER键。 12. 设置 LIMIT 数据输入模式。 13. 输入1.4的限定值，然后ENTER键。 14. 观察波形并检查反射回的SWR是否超过 1.4 (= 15.6 dB RL)，可参考表3（下表）
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图5 不符合标准的波形（不正常）
第九代Site Master S331L 手持式智能电缆和天线分析仪说明书
技术手册第九代Site Master™S331L手持式智能电缆和天线分析仪具有经典模式和高级模式2 MHz 到 4 GHz 电缆和天线分析仪50 MHz 到 4 GHz 功率计“Site Master 是站点制造商、安装者和维护者和无线服务提供商最值得信赖、最可靠和最值得推荐的电缆和天线分析仪”介绍安立公司非常荣幸的发布其第九代的高性能手持式智能电缆和天线分析仪Site Master™ S331L 。
S331L 全新的设计，是我们综合了我们多年的经验、用户的反馈、现场使用和最新的技术，研发出的最优性价比、专为现场使用、高可靠性、可信赖、结实并易用的智能电缆和天线分析仪。
S331L Site Master 手持电缆和天线分析仪与笔记本连接专为现场应用优化易于使用高效的扫描管理→大于8小时电池工作时间→待机模式和测试模式的快速切换→最高的射频抗干扰能力→内置InstaCal ™自动校准件模块- 快速，一次连接校准→FlexCal ™ 灵活校准模式- 一次校准覆盖所有频率→内置功率计→坚固并可靠→防冲击、灰尘和液体溅落设计→最小、最轻的Site Master ™→集成帮助功能→S331D-类似 经典模式→S331E-类似 高级模式 - 自定义快捷方式 - 增加标记数量 - 全屏显示→多个USB端口→800 x 480 7” TFT 触摸屏 - 大屏幕键盘 - 2个自定义字母数字键盘 - 36个使用字段组合快速命名键→背光键盘→内部存储 >1000 文件 - 存储扫描结果、设置、屏幕截图→快速预览存储的扫描曲线→电缆扫描工具(LST) 软件 - 编辑扫描, 重命名, 归档 - 生成 PDF 或 HTML 报告→标准的*.dat 扫描文件格式→兼容HHST软件 - 被操作人员广泛接受→SweepMasters DIRECT - 提供在线的测试结果传输服务电缆和天线分析仪特点结实，防尘和防滴溅，高可靠性，轻便和小巧Site Master S331L是一款结实、防尘和防水溅、高可靠性、经现场充分验证、并可随时工作的仪表。
WHO现场主文件编写指南
© World Health OrganizationWHO Technical Report Series, No.961, 2011附件14Annex 14WHO现场主文件编写指南1WHO guidelines for drafting a site master file11. 介绍Introduction2. 目的Purpose3. 范围Scope4. 现场主文件的内容Content of site master file附件Appendix现场主文件的内容Content of a site master file1. 介绍Introduction1.1 现场主文件是由药品制药商编写的，应当包含下列具体的信息：生产厂区的质量管理方针及活动、在指定的生产厂区实行的对药品生产操作的生产和/或质量控制以及在与其相邻的建筑物内所进行的任何紧密的完整的操作。
如果只有一部分药品生产操作在此厂区内进行，那么在现场主文件中只需要描述这些操作，例如分析、包装等。
The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, an SMF need only describe those operations, e.g. analysis, packaging, etc.1.2 当提交给监管机构时，现场主文件中应当包含对常规监督、有效计划及进行GMP检查有用的、关于制造商与GMP相关的活动的清晰信息。
sitemaster使用手册
目录一）Site Master 简介 (3)二）Site Master 操作面板介绍 (4)2．1 测试连接头面板 (4)2．2 按键（硬件） (5)2．3 软键 (7)2．4 符号 (14)三）Site Master 实际操作应用 (15)3．1 电源操作 (15)3．2 校准操作 (15)3．3 驻波比（回波损耗）和电缆损耗的测量 (18)3．4 DTF故障定位测量 (20)3．5 进行功率测试 (22)3．6 在频谱分析中进行测量 (23)3．7 设置参考电平 (24)四）Site Master软件工具使用 (24)4．1 通信口设置 (24)4．2 软件安装 (25)4．3 轨迹图捕捉 (25)五）Site Master自检出错代码 (26)六）Site Master打印功能 (29)一）S ite Master 简介Site Master 是一种手持的、用于测量驻波比/回波损耗（SWR/RL）的工具，同时还可以测试功率。
该仪器具有一个用来输入数据的键盘和一个液晶显示屏幕，可以在可选频率范围和可选距离内，提供反映SWR和RL的轨迹图。
Site Master是专门设计成在移动方便的环境中使用的，比较轻便，可手持，方便携带到任何场地使用，其内置电池可连续工作两个半小时，如在省电工作模式下可工作八小时。
Site Master 也有外部供电AC-DC适配器或汽车烟嘴适配器供电，这两个都是标准配件。
Site Master可以用来测量驻波比（SWR），回波损耗（RL），电缆插损以及在天馈系统中故障定位，功率监视也是一个可选的功能。
此外，在Site Master S114B和S332B中，还具有频谱分析功能。
显示的轨迹图可以利用频率标记点和一条阀值线，当测量实际值超过这条线时，可以在菜单中选择提供发声“BEEP”功能。
为了使仪器在较暗的环境下工作，可以通过面板调节液晶背景亮光。
Site Master外部结构：存放环境温度－20～75℃操作环境温度0～50℃重量 1.82公斤体积25.4×17.8×6.1二）Site Master 操作面板介绍2．1 测试连接头面板连接头和指示灯在测试面板上，其名称及描述如下：12.5－15VDC 电池充电接口，输入为12.5～15VDC (1100MA)。
世界卫生组织 工厂主文件 起草 指南
Working document QAS/10.378 July 2010 RESTRICTEDWHO GUIDELINES FOR DRAFTING A SITE MASTER FILEDRAFT FOR COMMENTSThe Prequalification Programme currently uses a site master file (SMF). Your feedback would be very much appreciated as to whether this SMF needs to be revised in light of new developments, e.g. by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Please address any comments on this proposal, by 1 September 2010 to Dr A.J. van Zyl, Head of Inspections, Prequalification Programme, World Health Organization, 1211 Geneva 27, Switzerland, fax: (+41 22) 791 4730 or e-mail: vanzyla@who.int with a copy to gaspardm@who.int and to bonnyw@who.int. During the past few years we have moved more towards an electronic system for sending out our working documents for comment, for convenience and in order to speed up the process. If you do not already receive our documents electronically, please let us have your e-mail address (to bonnyw@who.int) and we will add it to our electronic mailing list.© World Health Organization 2010 All rights reserved. This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and member organizations) without the permission of the World Health Organization. The draft should not be displayed on any web site. Please send any request for permission to: Dr A.J. van Zyl, Head of Inspections, Prequalification Programme, Quality Assurance and Safety: Medicines, Department of Essential Medicines and Pharmaceutical Policies, World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730; e-mail: vanzyla@who.int. The designations employed and the presentation of the material in this draft do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This draft does not necessarily represent the decisions or the stated policy of the World Health Organization.Working document QAS/10.378 page 2 SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/10.378: Guidelines for drafting a site master fileNeed for possible revision identified by WHO Prequalification May 2010 Programme Draft mailed out for comments Collation of comments received Presentation to the WHO Expert Committee on Specifications for Pharmaceutical Preparations Further action as necessary July-August 2010 September 2010 18-22 October 2010…Working document QAS/10.378 page 3GUIDELINES FOR DRAFTING A SITE MASTER FILE (SMF)A site master file (SMF) for each manufacturing site of a finished pharmaceutical product (FPP) listed in a product dossier, should be submitted on a CD or DVD to the Inspection unit. A SMF for each manufacturing site of active pharmaceutical ingredient (API) and contract research organization (CRO), listed in a product dossier, should be submitted on request from the Inspection unit. A SMF should be succinct and, as far as possible, not exceed 25 A4 pages. A SMF is a document prepared by the manufacturer containing specific and factual good manufacturing practice (GMP) information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the SMF need describe only those operations, e.g. analysis, packaging. Layout of the SMF Front page Table of contents Contents 1. General information1.1 Brief information on the firm (including name and address), relation to other sites, and, in particular, any information relevant to understanding the manufacturing operations. 1.2 1.3 Pharmaceutical manufacturing activities as licensed by the national authority. Any other manufacturing activities carried out on the site.1.4 Name and exact address of the site, including telephone, fax and 24-hour telephone numbers. 1.5 Type of products manufactured on the site and information about any specifically toxic or hazardous substances handled, mentioning the way they are manufactured (in dedicated facilities or on a campaign basis). 1.6 Short description of the site (size, location and immediate environment and other manufacturing activities on the site).Working document QAS/10.378 page 4 1.7 Number of employees engaged in production, quality control, storage and distribution. 1.8 Use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis. 1.9 Short description of the quality management system of the firm responsible for manufacture. 2. Personnel2.1 Organization chart showing the arrangements for quality assurance, including production and quality control. 2.2 Qualifications, experience and responsibilities of key personnel.2.3 Outline of arrangements for basic and in-service training and how records are maintained. 2.4 2.5 3. Health requirements for personnel engaged in production. Personnel hygiene requirements, including clothing. Premises and equipment3.1 Simple plan or description of manufacturing areas with indication of scale (architectural or engineering drawings not required). 3.2 Nature of construction and finishes.3.3 Brief description of ventilation systems. More details should be given for critical areas with potential risks of airborne contamination (schematic drawings of the systems are desirable). Classification of the rooms used for the manufacture of sterile products should be mentioned. 3.4 Special areas for the handling of highly toxic, hazardous, and sensitizing materials. 3.5 Brief description of water systems (schematic drawings of the systems are desirable), including sanitation. 3.6 Description of planned preventive maintenance programmes for premises and of the recording system. Equipment 3.7 Brief description of major equipment used in production and control laboratories (a list of equipment is not required).Working document QAS/10.378 page 5 3.8 Description of planned preventive maintenance programmes for equipment and of the recording system. 3.9 Qualification and calibration, including the recording system. Arrangements for computerized systems validation. Sanitation 3.10 Availability of written specifications and procedures for cleaning manufacturing areas and equipment. 4. Documentation4.1 Arrangements for the preparation, revision, and distribution of necessary documentation for manufacture. 4.2 Any other documentation related to product quality that is not mentioned elsewhere (e.g. microbiological controls on air and water). 5. Production5.1 Brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters. 5.2 Arrangements for the handling of starting materials, packaging materials, and bulk and finished products, including sampling, quarantine, release, and storage. 5.3 5.4 6. Arrangements for the handling of rejected materials and products. Brief description of general policy for process validation. Quality control6.1 Description of the quality control system and of the activities of the quality control department. Procedures for the release of finished products. 7. Contract manufacture and analysis7.1 Description of the way in which the GMP compliance of the contract accepter is assessed. 8. 8.1 8.2 Distribution, complaints and product recall Arrangements and recording system for distribution. Arrangements for the handling of complaints and product recalls.Working document QAS/10.378 page 6 9. 9.1 Self-inspection Short description of the self-inspection system. ***。
Site Master使用说明.
按 键 -- 软 键
在不同的模式下，软键分别代表不同的功能， 其功能标记在屏显右侧与软键相对应
按 键 -- 软 键
频率菜单 • F1 扫描开始频率值。按此键后输入数值， 按ENTER完成。
• F2
扫描结束频率值。按此键后输入数值， 按ENTER完成。
按 键 -- 软 键
距离菜单
• D1 • D2 距离开始值（虚拟值为0）。 按此键后输入数值，按ENTER完成
Site Master 使 用 说 明
福建先创工程技术部
Site Master的概要
• 具体介绍流程如下图所示：
优
势
优
势
目前使用的测试仪表有三种： • TDR（时域反射仪）专用于测故障点。 • HP8954E，专用于测SWR（驻波比）。 • WILTRON SITE MASTER用于测试频域特性 （SWR）与DTF（故障点定位）。 通常基站的60%到80%问题发生在电缆、接头和 天线上，而使用Site Master天馈线分析仪可 快速发现问题，并且从地面上就可以考察天线 特性，测量精确，使用方便,功能齐全。 下面我们就以S332B为例阐述如何正确使用Site Master系列产品
外
观
S332B 外 观 – 后面板
RF DETECTOR
RF OUT
RF IN
DC 电源 输入
9 针 RS232 接头
S331/2B 外 观 -- 功率显示和探头
RF Detector
S332B 外 观 – 和打印机连接
S332B 外 观 – 前面板
数据显示
曲线设置 /数字输入 键 软菜单键
测量状态 设置键
按
键
曲线设置/数字输入键
SITE MASTER FILE
1.6.Short Dห้องสมุดไป่ตู้scription of the site:
The site is located at the free industrial zone atNasrCity.Total site area isabout2500m2with built up area of about2000m2.
Eachproduct issubjected to appropriate types oftesting andcontrol according to the specifications approved bythe registrationauthorities and the redefined qualityparameters.Records generated from the whole processes concerned with the production of the productare well revisedand checkedbefore therelease of the product .Stabilityevaluation accordingto pre-defined protocoltomeet ICHguidelines and market needs is an essential requirementfor ourproducts.
工厂基本资料
• 列出分別從事品質管理、生產、品質控制、倉儲及發運的 員工人數。
參考: 組織结構圖
總經理
品質管理部門主管
銷售部門主管 生產部門主管 品質保證經理
品質控制經理 、
4.廠房與設備
4.1 廠房設施 • 簡述工廠，包括廠區的面積和建築物清單。如果生產作業係針對不同市場 如本地、歐盟、美國等需求而在廠區內不同建築物進行時，應列出各棟建築 物之標的市場(如果未在1.1項下加以區分)；
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參考: 實驗室信息管理系統(Laboratory Information Management System,LIMS)
製藥行業品質管理系統軟件,特點是: • 規範—建立品質管理體系 • 可控—實現統一品質監管平臺 • 減耗—為企業節約成本 • 整合—資源整合、提高工作效率
中國內地很多製藥企業已引入，如四川某製藥廠,珠海保稅 區某合成製藥廠引入了珠海南方軟件園的FE LIMS系統。
SMF反映工廠目前的狀況
提交認證機構（最好有電子版）
表明製造廠商對GMP的認證已經準備好了！
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2.4 品質風險管理
• 簡述所運用的品質風險管理方法；
• 品質風險管理的範圍與重點，包括簡述在母公司階層所實 施以及在各子公司所實施的任何活動。應提及在供應品的 连續性評估中品質風險管理系統的應用。
中國GMP（2010版）：“品質風險 管理是在整個產品生命週期中採 用前瞻或回顧的方式，對品質風 險進行評估、控制、溝通、審核 的系統過程。應根據科學知識及 經驗對品質風險進行評估，以保 證產品品質。品質風險管理過程 所採用的方法、措施、形式及形 成的文件應與存在風險的級別相 適應。”
• 列舉該廠區最近5年內接受GMP核查的清單，包括日期及執行核查的主管 機構名稱/國家。如有有效的GMP證明書，將其複製件列為附件3。
《〈场地管理文件〉编写指导原则(试行)》
《场地管理文件》编写指导原则（试行）《场地管理文件》（Site Master File，SMF）是指由药品生产企业编写的药品生产活动概述性文件，针对企业每个生产地址建立，至少应当包含质量管理策略及在本生产地址进行的药品生产操作和质量控制活动，如有其它生产活动，也应当说明。
《场地管理文件》应当包括该生产地址进行的所有药品生产活动，如某一药品的生产、包装、贴签、检验、仓储等未在同一地址，各地址的《场地管理文件》应当包含本地址对应的药品生产活动。
《场地管理文件》应当简明扼要，但应当包含足够的信息，尽可能采取列表、图纸等简要方式，必要时可以附件形式对关键部分做进一步描述。
《场地管理文件》正文部分通常不超过20页（A4纸）。
《场地管理文件》是企业质量管理文件体系的一部分，应当按照《药品生产质量管理规范》的有关要求进行管理，建立文件编号、版本号、生效日期、变更历史等。
每个附件可有单独的生效日期和文件修订历史，单独更新。
《场地管理文件》的格式及具体内容如下：1企业概况1.1企业基本信息1.1.1企业名称、注册地址1.1.2生产地址、本生产地址的生产范围1.1.3企业质量负责人、本生产地址联系人的联系方式（应24小时内随时可联系，包括固定电话、手机、电子邮件等）1.2药品生产相关活动1.2.1提供药品生产许可证编号，简要描述本生产地址获得省级药品监督管理部门批准的许可范围。
1.2.2除药品生产许可范围内的生产活动，本生产地址进行的其它生产活动，包括药品生产许可范围之外的其它制药和非制药活动。
1.2.3简要描述本生产地址生产的药品情况，例如药品剂型、品种数量等，并明确本生产地址是否有处理高毒性、高致敏性(如青霉素类)、高活性物料的生产活动。
1.2.4生产场地内生产车间及生产线的设置情况。
简要描述场地的生产车间、每个车间内的生产线、药品生产场地统一编码（如有）等，提供生产场地内的生产车间、生产线及关键设备清单（附表1）。
场地主文件资料
制备制药工厂基本资料 Site Master File （说明备忘录）（台湾）
制备制药工厂基本资料 Site Master File （说明备忘录） C.1 总则
C.1.1 简介工厂数据(包括厂名、厂址)，其它相关之厂地，尤其是为了解 生产作业之相关数据。 指示： C.1.1 以不超过 250 字(一张 A4 纸)简述工厂的作业项目及本报告主题工厂 以外之其它厂地。 C.1.2 主管机关核准之药厂作业项目 指示： C.1.2 举证主管机关核发之相关档，注明文件有效期间(假使当事国给予文 件之效期，任何情况及条件限制应明列清楚)。 C.1.3 该厂地其它作业项目。 指示： C.1.3 包括药品及非药品类之作业项目。(参考 C.1.6) C.1.4 该厂地之名称及明确地址，包括电话、传真及 24 小时联络电话。 指示： C.1.4 厂名及厂址
PDF 文件使用 "pdfFactory Pro" 试用版本创建
C.3.9 合格、确效及校正(750 字/三张 A4 纸) C.3.9.1 简述公司之一般政策及合格、确效之计划书(预测性及追溯性)。 C.3.9.2 重要仪器是否有定期再确效。 C.3.9.3 应在这儿或于制造段落 5.4 段概述制程确效。 C.3.9.4 描述核准贩卖或开发阶段与确效批次之制度。 C.3.9.5 如何处理计算机确效(包括软件确效)。 C.3.9.6 描述仪器设备之校正策略及记录保存方法。
WHO现场主文件编写指南
© World Health OrganizationWHO Technical Report Series, No.961, 2011附件14Annex 14WHO现场主文件编写指南1WHO guidelines for drafting a site master file11. 介绍Introduction2. 目的Purpose3. 范围Scope4. 现场主文件的内容Content of site master file附件Appendix现场主文件的内容Content of a site master file1. 介绍Introduction1.1 现场主文件是由药品制药商编写的，应当包含下列具体的信息：生产厂区的质量管理方针及活动、在指定的生产厂区实行的对药品生产操作的生产和/或质量控制以及在与其相邻的建筑物内所进行的任何紧密的完整的操作。
如果只有一部分药品生产操作在此厂区内进行，那么在现场主文件中只需要描述这些操作，例如分析、包装等。
The site master file (SMF) is prepared by the pharmaceuticalmanufacturer and should contain specific information about the qualitymanagement policies and activities of the site, the production and/or qualitycontrol of pharmaceutical manufacturing operations carried out at the namedsite and any closely integrated operations at adjacent and nearby buildings.If only part of a pharmaceutical operation is carried out on the site, an SMFneed only describe those operations, e.g. analysis, packaging, etc.1.2 当提交给监管机构时，现场主文件中应当包含对常规监督、有效计划及进行GMP检查有用的、关于制造商与GMP相关的活动的清晰信息。
SMF编写指导原则
Guidelines for drafting a Site Master File (SMF)A site master file should be succinct and, as far as possible, not exceed 25 A4 pages.现场主文件应尽可能简短明了，不能超过25页A4纸Layout of the SMF: 现场主文件设计Front page 封面Table of contents目录Contents:内容1. General information 概述1.1 Brief information on the firm (including name and address), relation to other sites, and, in particular, any information relevant to understanding the manufacturing operations.关于企业(包括名称和地址)的简要描述, 包括其他与生产有关的内容。
1.2 Pharmaceutical manufacturing activities as licensed by the national authority.政府机关允许的药品生产活动1.3 Any other manufacturing activities carried out on the site现场其他生产活动1.4 Name and exact address of the site, including telephone, fax, and 24-hour telephone numbers. 详细的地址，以及电话、传真、24小时电话1.5 Type of products manufactured on the site, and information about any specifically toxic or hazardous substances handled, mentioning the way they are manufactured (in dedicated facilities or on a campaign basis). 现场生产的产品类型及对有毒有害物质的处理方法1.6 Short description of the site (size, location, and immediate environment and other manufacturing activities on the site). 厂区位置、面积及周围环境的描述1.7 Number of employees engaged in production, quality control, storage, and distribution.从事生产、质量管理、仓储和销售的职工人数1.8 Use of outside scientific, analytical, or other technical assistance in relation to manufacture and analysis. 委外加工和委外检验1.9 Short description of the quality management system of the firm responsible for manufacture. 质量管理体系描述2. Personnel 人员2.1 Organization chart showing the arrangements for quality assurance, including production and quality control. 质量保证体系组织机构图，包括生产和质量管理2.2 Qualifications, experience, and responsibilities of key personnel. 关键人员简历表2.3 Outline of arrangements for basic and in-service training and how records are maintained.人员培训及其记录2.4 Health requirements for personnel engaged in production. 参与药物生产职工的体检证明2.5 Personnel hygiene requirements, including clothing. 职工卫生要求，包括着装3. Premises and equipment Premises 厂房3.1 Simple plan or description of manufacturing areas with indication of scale (architectural or engineering drawings not required). 生产布局图（并非建筑工程图），标明比例3.2 Nature of construction and finishes. 建筑和装饰的性质3.3 Brief description of ventilation systems. More details should be given for critical areas with potential risks of airborne contamination (schematic drawings of the systems are desirable). Classification of the rooms used for the manufacture of sterile products should be mentioned. 空气净化系统描述（系统简图），必须提供可能产生空气污染的临界面积，生产区域的洁净级别划分3.4 Special areas for the handling of highly toxic, hazardous, and sensitizing materials. 处理有毒、有害、易燃、易爆等危险品的特殊区域3.5 Brief description of water systems (schematic drawings of the systems are desirable), including sanitation. 水系统描述（系统简图），包括消毒设施3.6 Description of planned preventive maintenance programmes for premises and of the recording system. Equipment设备维修计划及其记录的描述3.7 Brief description of major equipment used in production and control laboratories (a list of equipment is not required). 生产及检验的关键设备一览表3.8 Description of planned preventive maintenance programmes for equipment and of the recording system. 维修计划及其记录的描述3.9 Qualification and calibration, including the recording system. Arrangements for computerized systems validation. Sanitation 验证，校验，包括记录系统，计算机系统，卫生设施3.10 Availability of written specifications and procedures for cleaning manufacturing areas and equipment. 现场及设备清洁的现行有效程序4. Documentation 文件4.1 Arrangements for the preparation, revision, and distribution of necessary documentation for manufacture. 文件的编写、修改及发放等的管理制度4.2 Any other documentation related to product quality that is not mentioned elsewhere(e.g., microbiological controls on air and water). 与产品质量相关的其他文件，包括对空气和水的微生物要求等5. Production 生产5.1 Brief description of production operations using, wherever possible, flow sh eets and charts specifying important parameters. 生产工艺流程图5.2 Arrangements for the handling of starting materials, packaging materials, and bulk and finished products, including sampling, quarantine, release, and storage. 对原辅料、包装材料、成品的贮藏、取样、检验、放行等管理制度5.3 Arrangements for the handling of rejected materials and products.不合格原料及产成品处理程序5.4 Brief description of general policy for process validation. 生产关键过程控制描述6. Quality control 质量控制6.1 Description of the quality control system and of the activities of the quality control department. Procedures for the release of finished products. 对质量控制体系及其活动进行描述，产品放行流程。
GMP文件-场地主文件
Site Master File起草人：日期：***/QA经理审核人：日期：***/质量总监批准人：日期：***/总经理生效日期：yyyy．mm．dd 复审日期：yyyy．mm．dd 颁发部门：质量管理中心分发部门：分发序号：目录1目的PURPOSE (3)2职责RESPONSIBILITY (3)3适用范围SCOPE (3)4参考文献REFERENCE (3)5内容PROCEDURE (3)5.1GENERAL INFORMA TION ON THE MANUFACTURER (3)5.2QUALITY MANAGEMENT (4)5.3PERSONNEL (9)5.4PREMISES AND EQUIPMENT (10)5.5DOCUMENTATION (13)5.6PRODUCTION (14)5.7QUALITY CONTROL (18)5.8DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALLS (18)5.9SELF-INSPECTIONS (20)6附件ATTACHMENTS (21)7文件变更历史REVISION HISTORY (21)1目的PurposeThis file is mainly to describe the specific information about the quality management policies and activities of the site, the production and quality control of pharmaceutical manufacturing operations carried out at the named site.2职责ResponsibilityQuality department is responsible for preparing, reviewing and approval of the document and keeps the update according to the actual status of site and regulatory requirements.Other relevant departments support to provide latest information to quality department.3适用范围ScopeThis file is suitable for all kinds of manufacturing operations such as production, packaging and labelling, testing, relabeling and repackaging of all types of medicinal products.4参考文献Reference[1]WHO guidelines for drafting a site master file, WHO TRS No. 961, 2011.[2]The rules governing medicinal products in the European Union, V olume 4 GMP medicinalproducts for Human and Veterinary Use, Explanatory notes on the preparation of a Site Master File5内容Procedure5.1General information on the manufacturer5.1.1Contact information on the manufacturer⏹N ame and official address of the ma nufacturer;Name of the manufacturer: **** Co., Ltd.Official address of the manufacturer: **** Province, P.R. China.⏹Names and street addresses of the site, buildings and production units located onthe site;Manufacturing site: ****Province, P.R. China. The company has an occupiedfloor space of ****m², which include office building, API workshops, QClaboratory, reserved workshop and warehouse. The API workshops are dividedinto power workshop, the 1st workshop, the 2nd workshop and the 3rd workshop.⏹Contact information of the manufacturer including 24-hour telephone number ofthe contact personnel in the case of product defects or recalls;Contact person: ***Tel:+86-****; +86-****Recall event 24-hour contact person: Mr. ****Recall event 24-hour Tel: +86-****; +86-****⏹I dentificat ion number of the site as e.g. global positioning system (GPS) details,D-U-N-S (Data Universal Numbering System) number (a unique identificationnumber provided by Dun & Bradstreet) of the site or any other geographicallocation system.Geographical location: E:***°**′****″, N:***°**′***″5.1.2Authorized pharmaceutical manufacturing activities of the site⏹Copy of the valid manufacturing authorization issued by the relevant competentauthority in Annex 1; or when applicable, reference to the EudraGMP database. Ifthe competent authority does not issue manufacturing authorizations, this shouldbe stated;Please see Annex 1.⏹Brief description of manufacture, import, export, distribution and other activitiesas authorized by the relevant competent authorities including foreign authoritieswith authorized dosage forms/activities, respectively; where not covered by themanufacturing authorization;The company does not involve the import, export, distribution and other activitiesof other products other than the authorized manufacturer.⏹Type of products currently manufactured on-site (list in Annex 2) where notcovered by Annex 1 or the EudraGMP database;The company does not involve this situation.⏹L ist of GMP inspections of the site within the last five years; includi ng dates andname/country of the competent authority having performed the inspection. A copyof the current GMP certificate (Annex 3) or reference to the EudraGMP databaseshould be included, if available.The company has received GMP inspections within the last five years are shown in Table 1-1.The copy of the current GMP certificate is shown in Annex 3.5.1.3Any other manufacturing activities carried out on the siteThe company has no other manufacturing activities.5.2Quality management5.2.1The quality management system of the manufacturer⏹Brief description of the quality management systems run by the company andreference to the standards used;The company always regards quality management as the core and establishesand perfects a complete quality management system based on the laws andregulations such as the Chinese GMP (2010 version), WHO GMP, ICH Q7, etc.The company has set up the quality department under the leadership of thegeneral manager, which is responsible for the quality management andinspection of all products of the company, and is not subject to interference fromother departments and personnel. The quality department has a quality assuranceoffice (QA) and a laboratory (QC). QA is responsible for quality managementdocuments, related verification, deviations, changes, and other qualitymanagement work, and the company's quality supervision work. QC is fullyresponsible for the raw materials, packaging materials, intermediate products tothe inspection of finished products, as well as the management of sampleretention, stability inspection and testing equipment and reagents. The company'squality management system is complete and effectively regulates the behaviorand working procedures of relevant personnel. All levels of personnel strictlyimplement GMP and company documents to ensure that the production ofproducts meets the requirements of GMP, thus ensuring the quality of productsand accomplishing the company's quality objectives. The quality standards of thecompany's reference implementation include the Ch.P.2010, E.P.8.0, E.P.9.5,B.P.2010, etc.⏹Responsibilities related to the maintaining of the quality system including seniormanagement;The key personnel involved in the operation of the company's qualitymanagement system are: general manager, qualified person, QA office director,laboratory director, production department minister, etc.Responsibilities of general manager : Responsible for the daily management ofthe company and responsible for providing the necessary resources, rationalplanning, organization and coordination to ensure that the quality departmentindependently performs its duties.Qualified person: According to the laws and policies of relevant statedepartments, preside over the company's pharmaceutical productionmanagement, and responsible for drug production, safety and fire prevention,equipment safety, product sales, and responsible for the quality assurance workof the whole plant, and responsible for the impact of quality problems due toquality problems. Responsible for release of materials and APIs.Responsibilities of QA office director: Under the leadership of the minister ofquality department, responsible for the organization and implementation of thework of the department.Responsibilities of laboratory director :Under the leadership of the minister ofQuality Assurance, responsible for the inspection of raw materials, packagingmaterials, intermediate products, finished products , process water, etc.Responsibilities of the minister of production: The minister of production isresponsible for the production of the company, ensuring that the drugs areproduced and stored in accordance with the approved technical procedures toensure the quality of the drugs.⏹Information on activities for which the site is accredited and certified, includingdates and contents of accreditations, and names of accrediting bodies.The company successfully passed the Chinese GMP (2010 version) certificationby **** Market and Quality Supervision and Administration Committee (now**** Drug Administration) in 2017.The scope of certification is APIs including***********.5.2.2Release procedure of finished products⏹D etailed description of qualification requirements (education and workexperience) of the authorized person(s)/qual ified person(s) responsible for batchcertification and releasing procedures;The qualified person should have at least a bachelor degree in pharmacy orrelated professional (or intermediate professional technical title or licensedpharmacist qualification), have at least five years of practical experience inpharmaceutical production and quality management, and have engaged in drugproduction process control and quality inspection.⏹G eneral description of batch certification and releasing procedure;The workshop director reviews product batch production records.The laboratory director reviews the batch analytical records and signs theanalytical report form after the verification.QA reviews the production records and analytical records.After the QA personnel have reviewed, the minister of quality assurance willjudge the handling of the product, draw conclusions, and sign the release orscrapping documents.⏹Role of authorized person/q ualified person in quarantine and release of finishedproducts and in assessment of compliance with the marketing authorization;The qualified person assumes the responsibility of product release, ensuring thatthe production and inspection of each batch of released products are incompliance with relevant regulations, drug registration requirements and qualitystandards.⏹The arrangements between autho rized persons/qualified persons when severalauthorized persons/qualified persons ar e involved;The company only has one qualified person.⏹Statement on whether the control strategy employs process analytical technology(PAT) and/or real-time release or parametric release.The company does not have process analytical technology (PAT).5.2.3Management of suppliers and contractors⏹ A brief summary of the establishment/knowledge of supply chain and theexternal audit programme;The company has established the "Management Regulations on the Audit,Evaluation and Approval of Suppliers". The supply storage department can onlypurchase raw materials and packaging materials produced by qualified suppliers,and QA and QC can only inspect the raw materials and packaging materials ofqualified suppliers. Production departments can only use the raw materials andpackaging materials of qualified suppliers. Therefore, the company has amaterial supplier audit, evaluation, review and analysis of material qualityinspection results, quality complaints and non-conforming records related to thesystem. List the supplier audit plan every year and audit the supplier as plannedto ensure that the quality of the supplied materials is in accordance with thespecifications.⏹ A brief description of the qualification system of contractors, manufacturers ofAPIs and other critical materials suppliers;The quality management department organizes the enterprise risk assessment team to determine the safety level of the materials according to the degree of risk to the raw materials, auxiliary materials and packaging materials to be procured. According to the degree of influence on the quality and safety of drugs, the materials can be divided into two categories: A and B. The flow chart for audit of material classification is shown in Figure 2-1.Figure 2-1 The flow chart for audit of material classificationThe company's audit of suppliers includes initial audits, daily audits, and regular audits. The flow chart of supplier audit, evaluation and approval is shown in Figure 2-2.Figure 2-2 The flowchart of supplier audit, evaluation and approval⏹Measures taken to ensure that products manufactured are compliant withtransmitting animal spongiform encephalopathy (TSE) guidance;TSE is not involved in the production of APIs in our company. In the audit of thesupplier of the starting materials, in addition to auditing its production process, itis required to issue a BSE/TSE statement.⏹Measures adopted where substandard/spurious/falsely-labelled/falsified/counterfeit medical products, bulk products (i.e. unpacked tablets), APIs orexcipients are suspected or identified;For areas with high risk of fraud in raw materials, the quality departmentstrengthens the management of suppliers' raw material identification experimentsand the management of supplier audits and evaluations, and regularly reviewsand analyzes material quality inspection results, quality complaints andunqualified processing records. If there are major problems in material qualityproblems or production conditions, processes, quality standards and inspectionmethods that may affect quality, the relevant on-site quality audit will be carriedout as soon as possible. Ensure that the quality of all materials supplied meetsthe specifications.⏹U se of outside scientific, analytical or other technical assistance in relation tomanufacture and analysis;The company does not have a commissioned production situation.Drinking water in the company is inspected once a year by a third-partyinspection and testing institution with corresponding qualifications in accordancewith the “Sanitation Standards for Drinking Water” (GB5749-2006).The cleaning area and the microbial testing room of the company's fine bakingworkshop entrust a third-party inspection and testing institution withcorresponding qualifications to conduct a cleanliness test every year.⏹List of contract manufacturers and laboratories including the addresses andcontact in formation and flowcharts of supply chains for outs ourcedmanufacturing and QC activities, e.g. sterilization of primary packaging materialfor aseptic processes, testing of starting raw materials, etc., should be presentedin Annex 4;The company does not have contract manufacturing companies and laboratories.⏹Brief overview of the responsibility sharing between the contract giver andacceptor with respect to compliance with the marketing authorization (where notincluded under 2.2).The company does not involve this situation.5.2.4Quality risk management⏹Brief description of quality risk management (QRM) methodologies used by themanufacturer;The company has established a quality risk management organization with theparticipation of the company's leadership and the quality department, which isresponsible for the overall quality risk management. The risk managementorganization is established by the technical backbone group of the qualitydepartment, sales department, engineering department, production departmentand various workshops. The quality risk management team shall be establishedby each department. The quality risk management team shall initiate the riskassessment of the quality risk of the department and report it to the qualitydepartment. The quality department shall propose the risk control measures to bereported to the risk management agency for review, approval andimplementation.⏹Scope and focus of QRM including brief description of any activities which areperformed at corporate level, and those which are performed locally. Anyapplication of the QRM system to assess continuity of supply should bementioned.The focus of quality risk management mainly involves materials, suppliermanagement risks, production process risks, inspection process risks, productshipping and recall process risks, and quality risks caused by critical changes andmajor deviations. At the same time, through the retrospective analysis of productquality, the trend or deviation of product quality is found to ensure productquality.5.2.5Product quality reviews⏹Brief description of methodologies used.The company has established the “Product Quality Review ManagementRegulations”, and the product quality review cycle is one year. The review itemsinclude raw and auxiliary materials/inner packaging materials, intermediatecontrol of production processes, finished product inspection results, publicsystems, stability investigation and adverse trend analysis, etc.The analytical methods used in the quality review are as follows:(1) Data statistics: The data statistics are sorted and described, and the averagevalue (⎺x) and standard deviation (δ) of each parameter are calculated using theExcel table formula, and the corresponding management limits and action limitsare calculated. Of which: management limit = x±2δ; action limit = x±3δ.(2) Trend analysis: Based on the description of the statistical data, a line chart isgenerated to further analyze the trend, and the abnormal factors in the processare predicted, and the process quality is evaluated.5.3Personnel⏹Organization chart showing the arrangements for quality management,production and quality control positions/titles in Annex 5, including seniormanagement and authorized person(s)/qualified person(s);See Annex 5⏹Number of employees engaged in the quality management, production, qualitycontrol, storage and distribution, respectively.The number of personnel engaged in quality management, production, qualitycontrol, storage and distribution is shown in Table3-1.Table 3-1 Forms of the company's quality management, production, qualitycontrol, warehousing and distribution personnel5.4Premises and equipment5.4.1Premises⏹Short description of plant: size of the site and list of buildings. If the productionfor different markets, i.e. for local country or regional economic areas, takesplace in different buildings on the site, the buildings should be listed withdestined markets identified (if not identified under 1.1);The company has an occupied floor space of ****m², which include officebuilding（****m2）, API workshops(****m2), QC laboratory（****m2）, reservedworkshop and warehouse(****m2). The API workshops are divided into powerworkshop, the 1st workshop, the 2nd workshop and the 3rd workshop.⏹Simple plan or description of manufacturing areas with indication of scale(architectural or engineering drawings are not required);The 1st workshop is for **** manufacturing which includes **** crudepreparation workshop and refining & packing zone 1. The *** crude preparationworkshop is a 10.5m high single layer. In addition, there is a 3-meters-highsingle-layer steel platform. This workshop covers an area of ****m2 and it is ageneral synthesis zone. **** refining workshop, namely refining & packing zone1, is a single layer except that the drying room is on the second floor. Therefining workshop has an occupied floor space of *** m2 and the constructionarea is **** m2, of which *** m2is clean area. The production capacity is***ton/year.The company does not have the production by different buildings facingdifferent markets.⏹L ayouts and flowcharts of the production areas (in Annex 6) showing the roomclassification and pressure differentials between adjoining areas and indicatingthe production ac tivities (i.e. compounding, filling, storage, packaging, etc.) inthe rooms;Please see Annex 6.⏹Layouts of warehouses and storage areas, with special areas for the storage andhandling of highly toxic, hazardous and sensitizing materials indicated, ifapplicable;The warehouse floor plan is shown in Figure 4-1.********Figure 4-1: Warehouse floor plan⏹B rief description of specific storage conditions if applicable, but not indicated onthe layouts.The finished product bank is used to store ****, niacin and niacin finishedproducts. It is a room temperature warehouse with a storage temperature of10-30 ℃and is equipped with a temperature regulation system. When thetemperature in the warehouse is shown to be higher than 28℃ or less than 12℃,the air-conditioning is turned on so that the warehouse temperature is maintainedwithin 10-30℃.The raw material & packaging material warehouse is an ordinary warehouse, andthe storage temperature condition is less than 40℃. When the warehousetemperature is higher than 39 ℃, ventilation and other cooling measures aretaken. The company plans to increase the temperature regulation system in someof the material warehouses and set its stability to less than 30 ℃.Each warehouse is equipped with lighting, ventilation, shading, mosquito androdent control, fire protection and cleaning facilities.The loading and unloading areas of the finished warehouse and the raw material&packaging material warehouse are all equipped with sheds to avoid the impactof external weather when loading and unloading.4.4.1.1 Brief description of heating, ventilation and air-conditioning(HVAC)systems⏹P rinciples for defining the air supply, temperature, humidity, pressuredifferentials and air-change rates, policy of air recirculation (%).Our air conditioning purification system is designed according to therequirements of Class D clean area in the GMP. The air-conditioning purificationsystem of the **** refinery area consists of two groups of clean air conditioningunits, JK1 and JK3（no return air, there is a straight exhaust system）, JK1 airsupply is ****m3/h, JK3 air supply is ****m3/h., air exchange frequency:≥15times/h, The pressure difference between the clean area and the non-cleanarea is ≥10Pa, the pressure difference (negative pressure) ≥5Pa for the adjacentlevel, the temperature is 18-26°C, and the humidity is 45-65%RH.4.4.1.2 Brief description of water systems⏹Quality references of water produced;The company's purified water quality standards are established in accordancewith the requirements of the second edition of the Chinese Pharmacopoeia 2015edition. The water supply system uses dynamic circulation and the storage timeis less than 24 hours.⏹Schematic drawings of the systems in Annex 7.Please see Annex 7.4.4.1.3 Brief description of other relevant utilities such as steam, compressed air, nitrogen, etc.⏹Steam and refrigeration systemProduction heat and winter heating are supplied by the industrial park.The company has a water-cooled screw low-temperature industrial chiller for thecentral clean air conditioning of the clean room. The laboratory uses cooling airconditioners for summer cooling and cold brine system for production.⏹Water supply systemPure water is used to prepare raw water, circulating cooling water to replenishwater, workshop floor and equipment cleaning water, and workers' domesticwater mainly comes from the park water supply pipe network.Production, laboratory and equipment cleaning water are pure water produced bywater treatment plants.⏹Power supply systemThe power source of the plant is the **** Power Supply Station. The companybuilt a 630kVA transformer and provided its own diesel generator as a backuppower source.⏹Compressed air systemIn the power plant , there is a screw air compressor that provides compressed airand is equipped with an air pressure storage tank (1.5m3) and a dryer.⏹Vacuum systemThe power workshop provides vacuum for the production workshop through twotypes of vacuum pumps, WLW-50B and WLW-100B. Each vacuum pump has aspare.5.4.2Equipment5.4.2.1Listing of major production and control laboratory equipment with critical pieces ofequipment iden tified should be provided in Annex 8.Please see Annex 8.5.4.2.2Cleaning and sanitation⏹Brief description of cleaning and sanitation methods of product contact surfaces(i.e. manual cleaning, automatic clean-in-place, etc.).The factory has established the “Stand ards for the Cleaning of Containers andAppliances in General Producti on Areas”and the operating procedures forspecific equipment cleaning standards. The cleaning methods of equipment andtools that are in direct contact with the drug are mainly manual cleaning.The cleaning agent used is purified water, the disinfectant is 75% medicinalethanol, and the 1 ‰ benzalkonium bromide disinfectant is used for disinfectionof equipment and containers, and is rotated every month. Ozone is used fordisinfection of the plant.Cleaning of containers and utensils: Clean once before the first use, and cleanonce after each use. The cleaning method is mainly washed with purified water.The cleaning period is 7 days, and disinfection is done every 7 days.Cleaning of equipment: The equipment that is in direct contact with the medicineis generally cleaned after each batch of use. The cleaning method mainly usesthe purified water to rinse the inner surface of the equipment, and wipes thesurface of the equipment with a rag. Normal production for six months forthorough cleaning (including disinfection), special cleaning for thoroughcleaning (including disinfection) (such as production stoppage, start-up;equipment overhaul; abnormalities may affect product quality), normalproduction , at the end of each month after cleaning, disinfect with a disinfectant.The clean area plant is cleaned once a day, thoroughly cleaned and disinfectedonce a month. Thorough cleaning (including disinfection) in special cases (suchas production stoppage, start-up, equipment overhaul; abnormalities may affectproduct quality); normal production is cleaned with disinfectant after cleaning atthe end of each month.The above cleaning methods have been verified.5.4.2.3Good manufacturing practices critical computerized systems⏹Description of GMP critical computerized systems (excluding equipment-specific programmable logic controllers (PLCs)).The company does not have a computerized management system in theproduction, storage departments and laboratory, only the computer connected tothe experimental instrument, and has formulated relevant regulations.5.5Documentation⏹Description of documentation system (i.e. electronic, manual);➢General documentThe company formulates the responsibilities of each department andpersonnel, formulates technical standards according to GMP standardsaccording to the duties of relevant personnel, and prepares standardmanagement procedures, standard operating procedures and safetymanagement procedures by relevant personnel according to technicalstandards, and then develops recording contents and formats by theseregulations. The verification documents are drafted, reviewed and approvedin accordance with the verification management procedures.➢Structure of the file systemThe structure of the company's file system is shown in Figure 5-1.Figure 5-1 Structure of the file system➢Classification of file systemsThe file system mainly includes seven parts: quality manual (QT), technicalstandard (TS), verification document (V), standard management procedure(SMP), standard operating procedure (SOP), recording, and securitymanagement. Classified by management type, including: personnel andorganization (HR), premises and equipment (EQ), materials and products(MP), validation and verification (VD), document management (DM),cleaning and sanitation management (CH) , quality management (QA),product shipment and recall (SS), quality control (QC), productionmanagement (PM).Each document consists of six parts: title, purpose, scope,procedures, attachments, and document revision.➢Document ManagementThe company's document management mainly includes the drafting ofdocuments, the review of documents, the approval and entry into force ofdocuments, the reproduction, distribution and archiving of documents, therevision of documents, the abolition, recovery and destruction of documents.⏹When documents and records are stored or archived off-site (includingpharmacovigilance data, when applicable): list of types of documents/ records;name and address of storage site; and an estimate of time required to retrievedocuments from the off-site archive.Our company does not involve documents and records are stored or archivedoff-site.5.6Production5.6.1Type of productsReferences to Annex 1 or 2 can be made.⏹Type of products manufactured including:➢List of dosage forms of both human and veterinary products which are manufactured on the site➢List of dosage forms of investigational medicinal products (IMP) manufactured for any clinical trials on the site, and when different from thecommercial manufacturing, information on production areas and personnel;The company does not involve the production of finished drugs. The mainproducts of the company are APIs (******).⏹Toxic or hazardous substances handled (e.g. with high pharmacological activityand/or with sensitizing properties);The company does not involve the operation of toxic or hazardous substances inthe production process.The small amount of hazardous chemicals used in the laboratory are strictlymanaged in accordance with the requirements of the public security department.⏹Product types manufactured in a dedicated facility or on a campaign basis, ifapplicable;The company does not involve.。
Site Master 使用rev
第一章 概述 第二章 测量驻波比的方法 第三章 天馈故障定位 第四章 使用注意事项和常见问题
附录：软件工具使用
第三章 天馈故障定位
• • 当驻波比大于设定指标（一般是1.5）时，需要使用DTF功能具体定位问题点 第一步：设置初始参数（最大距离、中心频率、电缆型号） – 选择主菜单中“MODE”选项 – 输入D1、D2的值（即起始与最大距离，一般取到天线的距离）， 按ENTER键确认 – 输入“Center Freq”的值，一般取测量频段的中间值，按ENTER键确认 – 按DOWN键，选择电缆型号（系统会自动显示该电缆的其他参数） – 一般常用的电缆有3种： • FSJ4－50B，即通常所用的1/2英寸跳线 • LDF5－50A，即通常所用的7/8英寸馈线 • LDF6－50A，即通常所用的5/4英寸馈线
第一章 概述 第二章 测量驻波比的方法 第三章 天馈故障定位 第四章 使用注意事项和常见问题 附录：软件工具使用
附录：软件工具使用
附录：软件工具使用
附录：软件工具使用
附录：软件工具使用
附录：软件工具使用
工具栏按钮作用
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������ 存储Save
������ 存储图形数据Copy plot data
Site Master 使用
学习完此课程，您将会：
– 掌握使用Site Master 测量驻波比的方法 – 掌握使用Site Master 进行故障定位的方法 – 掌握使用Site Master 进行测量图形导出
第一章 概述 第二章 测量驻波比的方法 第三章 天馈故障定位 第四章 使用注意事项和常见问题 附：软件工具使用
第二章 测量驻波比的方法
• 步骤4：读取测量的最大驻波比（SWR）数据 – 按菜单下的MARKER键（MAKERS，标记），打开一个 MAKERS（M1） – 选择EDIT ，用上/下键改变该M1对应距离值，读取需要测量 的范围内最大的SWR值 – 读取最大的SWR值还有另一种方法：按菜单下的MARKER 键，打开一个MAKERS后，选择PEAK，该MAKERS将自动 跳转到最大的SWR值所在频率
Site Master 操作手册
Site Master 操作手册第一章综述Site Master是手持式SWR/RL（驻波比/回损）测量仪器，可进行故障端点定位。
机内装有合成信号源，还有功率监测功能可供选择。
仪器面板上有数字输入键，大屏幕LCD可显示所选频率范围内SWR或RL的图形。
S331A中，故障断点定位功能是标准配置的。
测量数据可以通过软件转换成故障点位置的信息，该软件是Anritsu公司自带的。
Site Master带有可充电电池，充满电后，电池可连续工作2小时。
仪器也可直接接上12.5V （DC）使用，与此同时，也对内部电池进行了充电。
用内置能量保存特性可将电池寿命延长到8小时（一个工作日）。
第二章操作1测试面板标识说明12.5—15VDC 充电及外接电源输入，12.5—15VDC，600mA。
Battery Charging 灯亮时说明电池正在充电，充满电后指示灯将自动熄灭。
External Power 灯亮时说明Site Master是由外部充电器供电。
Serial Interface 串行接口，可接PC机（用软件时）或HP Deskjet 340打印机。
Test Port RF输出，阻抗50Ω（接被测件）。
RF Det RF检波器输入端。
检测功率时用。
2前面板操作标识说明将LCD的背景光打开或关闭。
（关闭背景光可节约电池）Auto Scale 自动刻度功能。
使显示分辨率最佳。
CAL 打开校准菜单。
用上/下箭头键和ENTER键来选择已存储在机内的校准状态（A或B）或关闭CAL。
ENTER 确认并执行选定的菜单和按键命令。
ESCAPE/CLEAR 退出当前操作和/或清除显示。
当某一参数正被编辑时，按此键将清除当前输入的数值而重新存入上一次有效输入。
再按此键，将关闭该参数。
在正常扫描过程中，按此键将回到上一层菜单。
LIMIT 叫出刻度菜单。
MARKER 取出标记菜单。
ON/OFF 仪器开关。
开机时，系统处于上次关机时存储的状态。
【知药大讲堂】如何构建SMF工厂主文件
【知药⼤讲堂】如何构建SMF⼯⼚主⽂件⽬录1.SMF简介2.国内SMF内容3.国内外SMF区别4.展望⽂：郝⽼师来源：知药学社整理：品⽵⼭⼈⼀、课堂语⾳如果构建SMF⼯⼚主⽂件来⾃知药学社00:0037:36⼆、SMF是什么Site Master File ,⼯⼚主⽂件，也称场地主⽂件。
1993年4⽉，国际药品监管公约/药品监管合作计划（PIC/S)⾸次发布了⼯⼚主⽂件相关的指导⽂件，作为制药企业编写⼯⼚主⽂件的技术指南。
2011年1⽉1⽇，该指导意见的第4次修订案⽣效。
SMF⽤于向药品进⼝国药品管理部门阐述本企业的设施及⽣产活动，以证明本企业遵守GMP。
SMF应包含⾜够的信息，但是加上附件不得超过25-30页。
以简单性计划、简略的原理布局图为⾸选。
SMF是监管部门⽇常监管和GMP认证制定现场检查计划和开展现场检査的依据和参考。
SMF是质量管理⽂件体系的⼀部分，应进⾏相应更新。
SMF应当有版本号、⽣效⽇期以及需进⾏审核的⽇期。
三、合适需要提交SMF国家药品审核查验中⼼1.2019年12⽉1⽇前的GMP认证2. 新品注册⽣产现场检查3.仿制药⼀致性评价现场检查四、国内SMF内容1.以之前药品GMP认证申请资料要求举例1.1 企业信息◆企业名称、注册地址；◆企业⽣产地址、邮政编码；◆联系⼈、传真、联系电话（包括出现严重药害事件或召回事件的24⼩时的联系⼈、联系电话）。
1.2 企业的药品⽣产情况◆简述企业获得药品监督管理部门批准的⽣产活动，包括进出⼝以及获得国外许可的药品信息；◆营业执照、药品⽣产许可证，涉及出⼝的需附上境外机构颁发的相关证明⽂件的复印件；◆获得批准⽂号的所有品种（可分不同地址的⼚区来填写，并注明是否常年⽣产，近三年的产量列表作为附件）序号、产品名称、规格（包装规格）、批准⽂号、⽣产车间（⼚区）、是否常年⽣产、近三年批量、批数、年产量◆⽣产地址是否有处理⾼毒性、性激素类药物等⾼活性、⾼致敏性物料的操作，如有应当列出，并应在附件中予以标注。