|
第三步：在公众号对话框输入关键词：HPLC确认 即可获得下载地址，然后就可以下载全文资料啦 特别提示：提取密码是：fzkx Example: 操作示范： 附：HPLC确认方案/报告（IQ+OQ+PQ）之IQ范文展示： Installation Qualification Protocol 安装确认（IQ）方案 INDEX目录 1. Purpose目的 2. Scope范围 3. Responsibility职责 4. Regulation and Guidance 法规和指南 5. Terms and Abbreviations术语及缩写 6. System Description 系统描述 7. Documentation Control Specification 文件管理规范 8. Test List测试项目列表 9. Test Description and Acceptance Criteria 测试描述和可接受标准 9.1 Personal Qualification人员的确认 9.2 Prerequisites先决条件 9.3 Module Qualification模块确认 9.4 Module Accessories Qualification模块附件确认 9.5 Module Installation Qualification模块安装确认 9.6 Software Version Controlling软件版本控制 10. Deviation Report偏差报告 11. List of Deviation 偏差清单 12. List of Attachment附件清单 13. Change Control变更控制 14. Execution Review and Approval执行的审核和批准 15. Index of Test Report 测试报告目录 Test Report 测试报告1 Personnel Qualification人员的确认 Test Report 测试报告2 Prerequisites 先决条件 Test Report 测试报告3 Module Qualification模块确认 Test Report 测试报告4 Module Accessories Qualification模块附件确认 Test Report 测试报告5 Module Installation Qualification模块安装确认 Test Report 测试报告6 Software Version Controlling软件版本控制 Test Report 测试报告7 List of Deviations偏差清单 Test Report 测试报告8 List of Attachment附件清单 Test Report 测试报告9 Execution Review and Approval执行的审核和报告的批准 1. Purpose目的The Installation Qualification (IQ) is to define the test procedures and acceptance criteria of the Axxxx 1200 HPLC of QC of XXX Pharmaceutical Co., Ltd. The Installation Qualification (IQ) would ensure that the key components that can directly affect the system are correctly installed and conform to the requirements of the design documents, that the supporting documents and quality documents are present at the site. The test and inspection results are to be recorded according to the validation scheme. 2. Scope范围The application scope of this Performance Qualification includes the Agilent 1200 HPLC （Equipment ID:zgb012）in the QC of XXX Pharmaceutical Co., Ltd. System No.: SYM-QC-01-HPLC-01 3. Responsibility职责XXX responsibility XXX的职责 ü IQ Protocol Writing XXX responsibilityxxxxx的职责 ü Review and approve this protocol before execution ü Provide personnel, when necessary, to assist in the operation of equipment and system ü Provide personnel, when necessary, to calibrate critical and non-critical measuring, recording, and/or controlling instrumentation ü Provide calibration certificate of any instruments utilised during the execution of this Protocol ü Protocol execution and data collection ü Define solution for non conformity ü Deviation report compilation ü Final report compilation ü Review and approve the protocol and test reports after successful execution 4. Regulation and Guidance 法规和指南To write this protocol have been used the following reference documents: ü (SFDA) GMP (2010 Revision) ü CP2015 中国药典2015 5. Terms and Abbreviations术语及缩写
6. System Description 系统描述The Axxxx HPLC （Equipment ID:xxxx）in the QC of XXX Pharmaceutical Co., Ltd. System No.: SYM-QC-01-HPLC-xx. The AXXXXX HPLC is composed of degasser, transfer pump, column heater, auto-sampler, detector and system software. It is used for assay test, identification and impurity analysis. 7. Documentation Control Specification 文件管理规范ü Recording pens 记录用笔： - Archive proof ink pens or marker pens shall be used. Blue pens are recommended.使用不消退的墨水笔和记号笔，推荐使用蓝色笔记录 ü Signature 签名： - Only authorized persons can sign on any documents.被授权的人员才能签署文件 - Unless otherwise specified, the full name shall be used as the signature..应签全名，除非文件另有规定 - The signature shall be readable.签名应该是可辨认的 - The signatures shall be consistent.签名应始终一致 ü Column filling 填写栏目： - All the columns shall be filled.所有栏目必须填写 - The full text shall be filled if it is the same as that in the field above.填写内容与上面栏目相同应重新填写 - If there is nothing to be filled in to an individual field, N/A (abbreviation for not applicable) shall be written in this field.若有单个栏目不需要填入内容，则在空白处填写英文字母“不适用”的简写“N/A”，以表示无此项内容。 - If there is nothing to be filled in more than one neighboring fields, such fields shall be crossed with a diagonal line, with “N/A” noted above the line and the signature and the date noted below the line. The signature and the date shall be written along the line on the same side as much as possible.填写记录时，若有多个栏目不需要填入内容，应用斜线划掉，斜线上方填写“N/A，下方签名和注明日期。签名及日期应尽量沿斜线同侧填写。
ü Correction of mistakes 更改错误： - When any mistakes are to be corrected immediately after the document has been complete, the correct record shall be entered and signed and dated. The original information shall be left clearly readable. - For example: January 1, 2010, signature and date 文件刚完成，立即更改的 在错误处划线， 填入正确的，签名和注明更改日期，确保原先信息仍清晰可识别。 如：2010年01月01日 签字，日期 - When any mistakes are to be corrected afterwards, besides conforming to the above requirements, the reasons for the correction must be noted and the possible influences shall also be assessed and noted. ü Date Recording Format 记录日期： - Four digits shall be used for the indication of the year, two digits for the month and another two for the date. 年用4位数表示，日和月用2位数表示 For example: 2010.01.01 如：2010.01.01 ü Use of Abbreviations 使用缩略语： - An abbreviation shall be noted in brackets immediately after the full name before it can be used in the rest of the document.在术语全称后的括号内注明缩写，然后才可以使用缩写。 ü Written Words and Names 书面语及名称： - Standard written words and names shall be used.使用规范的书面语及名称 - The names shall be consistent all through the document.文件前后名称要一致 8. Test List测试项目列表The test which will be performed in this protocol, are listed in the following form.
9. Test Description and Acceptance Criteria 测试描述和可接受标准9.1 Personal Qualification人员的确认Purpose 目的 Identify all people involve in protocol execution. Procedure程序 List and identify all personnel involved in the execution of the present protocol (Name. Signature, Initials and Department/Company). Acceptance Criteria可接受标准 All the operators are identified by Name, Signature, Initials and Department/Company. Test Report测试报告 Fill in Test Report No.1. 9.2 Prerequisites先决条件Purpose 目的 All prerequisites necessary to the PQ execution have been satisfied. Procedure程序 The installation of the HPLC has been finished. 高效液相色谱仪已完成安装。 Verify that IQ protocol has been approved. There should be a documented training for all people involved in the tests before initiation of IQ. Acceptance Criteria可接受标准 All the prerequisites must be satisfied before the beginning of the execution of IQ test. Test Report测试报告 Fill in Test Report No.2. 9.3 Module Qualification模块确认Purpose 目的 This test is to verify the consistency between the module list and site module. Procedure程序 Refer to the module list to verify the site module and record the type. Module list includes quaternary pump module, auto-sampler module, ultraviolet detector module and column heater module. Acceptance Criteria可接受标准 The module list should conform to site module, and record the type. Test Report测试报告 Fill in Test Report No.3. 9.4 Module Accessories Qualification模块附件确认Purpose 目的 This test is to verify the integration of each module accessories and relevant manual. Procedure程序 Check the integration of each component accessories and relevant manual. Pump：Operating Manual, Power Cord, LAN cable Auto-sampler：Operating Manual, Power Cord, LAN cable, 100ml Rhoedyne ,Package 200×2ml Vials Column heater：Operating Manual, Power Cord, LAN cable Detector：Operating Manual, Power Cord, LAN cable, UV Lamp Acceptance Criteria可接受标准 Each module accessories and relevant files are integral. Test Report测试报告 Fill in Test Report No.4. 9.5 Module Installation Qualification模块安装确认Purpose 目的 This test is to verify the module has been installed normally. Procedure程序 The width and depth of each module is suitable to complete the installation properly. Detector flow cell and UV lamp are easy to dismount. Pump, auto-sampler, column heater and detector unit are started normally, and the power button will indicate open status. The corresponding part on software controlling interface will show be usable. Acceptance Criteria可接受标准 Each module has been installed properly and is usable. Test Report测试报告 Fill in Test Report No.5. 9.6 Software Version Controlling软件版本控制Purpose 目的 This test is to verify the operating software version. Procedure程序 Record the current software version and verify the installation CD is readable. Acceptance Criteria可接受标准 Software version has been recorded, and the installation CD is readable and preserved properly. Test Report测试报告 Fill in Test Report No.6.
10. Deviation Report偏差报告Any deviations found during execution of this protocol will be handled according to the SOP for Deviation Management of XXX. Each deviation will be given a unique number and recorded in the deviation report. The deviations will be summarized in the deviation list. Use copies of the deviation report if necessary. 11. List of Deviation 偏差清单Record in the test report 7 all deviations found during PQ activities and indicate solution date. Use additional pages as required, Number the pages used. 12. List of Attachment附件清单Record in the test report 8 all documents attached to this protocol indicating the number and the title of relevant test report. Use additional pages as required, Number the pages used. 13. Change Control变更控制Any changed of the system will be submitted to a Change Control Procedure, in accordance with according to the SOP for Change Control of XXX. All Change Control Forms for the system will be filed. 14. Execution Review and Approval执行的审核和批准To conclude the performance of PQ and approval of the report. Record in the test report 9. 15. Index of Test Report 测试报告目录
▼ 望 您 关 注
制药工程论坛（CSPE），技术知识、交流社区、职业发展等医药新媒体平台， 为中国的制药工程从业人士提供最全面且专业的资讯，与中国同行一起促进制药行业的健康发展。制药工程论坛联合多名来自全球制药行业发达国家的GxP专家，以及国内知名GMP专家和国际注册顾问。以全球最新法规指南作为引领，以为制药质量体系为中心，通过强有力的项目管理团队，为制药行业提供符合FDA、EMA、CFDA、MHRA、PIC/S、WHO等要求的GxP合规服务。本着以客户为中心的理念，从研发质量体系咨询、技术转移咨询、验证咨询与测试、数据可靠性咨询、质量体系咨询、工艺开发咨询、运行卓越咨询、注册报批以及培训等方面为制药行业提供涵盖药品生命周期和法规性咨询服务。
|
|
|
来自： BookandHome > 《QC2》
