{"id":5417,"date":"2018-06-15T01:00:00","date_gmt":"2018-07-27T07:07:11","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e5%a5%bd%e6%b6%88%e6%81%af%ef%bc%81%e3%80%8ahplc%e7%a1%ae%e8%ae%a4iq-oq-pq%e6%96%b9%e6%a1%88-%e6%8a%a5%e5%91%8a%e3%80%8b%ef%bc%88%e6%ac%a7%e7%9b%9f-fda-gmp%e8%ae%a4%e8%af%81%e9%80%82%e7%94%a8\/"},"modified":"2018-07-27T15:07:13","modified_gmt":"2018-07-27T07:07:13","slug":"%e5%a5%bd%e6%b6%88%e6%81%af%ef%bc%81%e3%80%8ahplc%e7%a1%ae%e8%ae%a4iq-oq-pq%e6%96%b9%e6%a1%88-%e6%8a%a5%e5%91%8a%e3%80%8b%ef%bc%88%e6%ac%a7%e7%9b%9f-fda-gmp%e8%ae%a4%e8%af%81%e9%80%82%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/5417\/","title":{"rendered":"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA GMP\u8ba4\u8bc1\u9002\u7528\uff09\u5168\u5957\u8d44\u6599\u9650\u65f6\u514d\u8d39\u4e0b\u8f7d\uff01"},"content":{"rendered":"
\n

\"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA
<\/span><\/p>\n

\n
\n
\n
\n
\n
\"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/section>\n
\n
\n

\u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1\u7406\u8d44\u6df1\u4e13\u5bb6\uff0c\u591a\u5bb6\u5236\u836f\u516c\u53f8\u987e\u95ee\uff0c\u836f\u5b66\u7855\u58eb\u3002\u56fd\u5bb6\u5de5\u827a\u6838\u5bf9\u672a\u96e8\u7ef8\u7f2a\u4e4b\u9645\uff0c\u6210\u529f\u89e3\u51b3\u4e86\u591a\u5bb6\u5728\u4ea7\u4ea7\u54c1\u5904\u65b9\u3001\u5de5\u827a\u95ee\u9898\u3002\u5904\u65b9\u5de5\u827a\u7684\u4e8c\u6b21\u5f00\u53d1\uff0c\u514d\u8d39\u54a8\u8be2\uff0c\u5168\u7a0b\u4fdd\u5bc6\u3002\u90ae\u7bb1\uff1a1193686015@qq.com\u3002<\/span><\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n

<\/span><\/p>\n<\/section>\n

\n


<\/p>\n

\"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/p>\n


<\/p>\n

\u53ea\u9700\u7b80\u53553\u6b65\u5373\u53ef\u83b7\u5f97HPLC\u786e\u8ba4\u65b9\u6848+\u62a5\u544a\uff08\u6b27\u76df\/FDA GMP\u8ba4\u8bc1\u9002\u7528\uff09\u5168\u5957\u8d44\u6599\uff1b\u9650\u65f6\u514d\u8d39\u4e0b\u8f7d\uff1a<\/span><\/p>\n


<\/p>\n

\u7b2c\u4e00\u6b65\uff1a\u5c06\u672c\u6587\u7ae0\u8f6c\u53d1\u5230\u670b\u53cb\u5708\u6216\u4efb\u4e00\u5fae\u4fe1\u7fa4<\/span><\/span><\/strong><\/span><\/p>\n


<\/p>\n

\u7b2c\u4e8c\u6b65\uff1a\u5173\u6ce8\u516c\u4f17\u53f7\uff0c\u957f\u6309\u4e8c\u7ef4\u7801\u9009\u62e9\u5173\u6ce8<\/span><\/span><\/strong><\/span><\/p>\n

\"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/p>\n

\u7b2c\u4e09\u6b65\uff1a\u5728\u516c\u4f17\u53f7\u5bf9\u8bdd\u6846\u8f93\u5165\u5173\u952e\u8bcd\uff1aHPLC\u786e\u8ba4<\/span><\/strong><\/span><\/p>\n


<\/span><\/p>\n

\u5373\u53ef\u83b7\u5f97\u4e0b\u8f7d\u5730\u5740\uff0c\u7136\u540e\u5c31\u53ef\u4ee5\u4e0b\u8f7d\u5168\u6587\u8d44\u6599\u5566<\/span><\/p>\n


<\/p>\n

\u7279\u522b\u63d0\u793a\uff1a\u63d0\u53d6\u5bc6\u7801\u662f\uff1afzkx<\/span><\/strong><\/span><\/p>\n


<\/p>\n

Example: <\/span><\/strong><\/span>\u64cd\u4f5c\u793a\u8303\uff1a<\/span><\/strong><\/span>
<\/p>\n


<\/p>\n

\"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/p>\n


<\/p>\n

\u9644\uff1aHPLC\u786e\u8ba4\u65b9\u6848\/\u62a5\u544a\uff08IQ+OQ+PQ\uff09\u4e4bIQ\u8303\u6587\u5c55\u793a<\/em>\uff1a<\/span><\/strong><\/span><\/p>\n


<\/p>\n

Installation Qualification Protocol<\/span><\/strong><\/span><\/p>\n

\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09<\/em>\u65b9\u6848<\/span><\/strong><\/span><\/p>\n


<\/span><\/strong><\/p>\n

INDEX<\/span><\/strong>\u76ee\u5f55<\/span><\/strong><\/p>\n

 <\/span><\/strong>
<\/p>\n

1.\tPurpose\u76ee\u7684<\/span><\/em><\/span><\/p>\n

2.\tScope\u8303\u56f4<\/span><\/em><\/span><\/p>\n

3.\tResponsibility\u804c\u8d23<\/span><\/em><\/span><\/p>\n

4.\tRegulation and Guidance \u6cd5\u89c4\u548c\u6307\u5357<\/span><\/em><\/span><\/p>\n

5.\tTerms and Abbreviations\u672f\u8bed\u53ca\u7f29\u5199<\/span><\/em><\/span><\/p>\n

6.\tSystem Description \u7cfb\u7edf\u63cf\u8ff0<\/span><\/em><\/span><\/p>\n

7.\tDocumentation Control Specification \u6587\u4ef6\u7ba1\u7406\u89c4\u8303<\/span><\/em><\/span><\/p>\n

8.\tTest List\u6d4b\u8bd5\u9879\u76ee\u5217\u8868<\/span><\/em><\/span><\/p>\n

9.\tTest Description and Acceptance Criteria \u6d4b\u8bd5\u63cf\u8ff0\u548c\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/span>
<\/p>\n

9.1\tPersonal Qualification\u4eba\u5458\u7684\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

9.2\tPrerequisites\u5148\u51b3\u6761\u4ef6 <\/span><\/em><\/span><\/p>\n

9.3\tModule Qualification\u6a21\u5757\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

9.4\tModule Accessories Qualification\u6a21\u5757\u9644\u4ef6\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

9.5\tModule Installation Qualification\u6a21\u5757\u5b89\u88c5\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

9.6\tSoftware Version Controlling\u8f6f\u4ef6\u7248\u672c\u63a7\u5236 <\/span><\/em><\/span><\/p>\n

10.\tDeviation Report\u504f\u5dee\u62a5\u544a<\/span><\/em><\/span><\/p>\n

11.\tList of Deviation \u504f\u5dee\u6e05\u5355<\/span><\/em><\/span><\/p>\n

12.\tList of Attachment\u9644\u4ef6\u6e05\u5355<\/span><\/em><\/span><\/p>\n

13.\tChange Control\u53d8\u66f4\u63a7\u5236<\/span><\/em><\/span><\/p>\n

14.\tExecution Review and Approval\u6267\u884c\u7684\u5ba1\u6838\u548c\u6279\u51c6<\/span><\/em><\/span><\/p>\n

15.\tIndex of Test Report \u6d4b\u8bd5\u62a5\u544a\u76ee\u5f55
<\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a1 Personnel Qualification\u4eba\u5458\u7684\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a2 Prerequisites \u5148\u51b3\u6761\u4ef6 <\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a3 Module Qualification\u6a21\u5757\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a4 Module Accessories Qualification\u6a21\u5757\u9644\u4ef6\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a5 Module Installation Qualification\u6a21\u5757\u5b89\u88c5\u786e\u8ba4 <\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a6 Software Version Controlling\u8f6f\u4ef6\u7248\u672c\u63a7\u5236 <\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a7 List of Deviations\u504f\u5dee\u6e05\u5355 <\/span><\/em><\/span><\/p>\n

Test Report \u6d4b\u8bd5\u62a5\u544a8 List of Attachment\u9644\u4ef6\u6e05\u5355 <\/span><\/em><\/span><\/p>\n

  Test Report \u6d4b\u8bd5\u62a5\u544a9 Execution Review and Approval\u6267\u884c\u7684\u5ba1\u6838\u548c\u62a5\u544a\u7684\u6279\u51c6 <\/span><\/em><\/span><\/p>\n


<\/p>\n

1. <\/span>Purpose\u76ee\u7684<\/span><\/span><\/strong><\/h1>\n

The <\/span>Installation<\/span> Qualification (<\/span>I<\/span>Q) <\/span>is to <\/span>define the test procedures and acceptance criteria<\/span> <\/span>of the <\/span>Axxxx 1200 HPLC of QC <\/span>of XXX Pharmaceutical Co<\/span>., <\/span>Ltd.<\/span>
<\/span>\u672c<\/span>\u5b89\u88c5<\/span>\u786e\u8ba4\u662f\u4e3a\u4e86\u786e\u8ba4<\/span>XXX<\/span>\u8d28\u91cf\u63a7\u5236\u90e8<\/span>Axxxx1200\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\u7684\u5b89\u88c5\u7b26\u5408\u76f8\u5173\u7684\u6d4b\u8bd5\u6b65\u9aa4\u548c\u9a8c\u6536\u6807\u51c6<\/span><\/span>\u3002<\/span><\/p>\n

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.
<\/span>\u5b89\u88c5\u786e\u8ba4\u5c06\u786e\u5b9a\u76f4\u63a5\u5f71\u54cd\u7cfb\u7edf\u7684\u5173\u952e\u90e8\u4ef6\u88ab\u6b63\u786e\u5730\u5b89\u88c5\uff0c\u5e76\u7b26\u5408\u8bbe\u8ba1\u6587\u4ef6\u9700\u6c42\uff1b\u786e\u5b9a\u652f\u6301\u6587\u4ef6\u3001\u8d28\u91cf\u6587\u4ef6\u5728\u73b0\u573a\u3002\u6d4b\u8bd5\u548c\u68c0\u67e5\u7684\u7ed3\u679c\u5c06\u6309\u7167\u8be5\u9a8c\u8bc1\u65b9\u6848\u8fdb\u884c\u8bb0\u5f55\u3002<\/span><\/p>\n

2. <\/span>Scope<\/span><\/strong>\u8303\u56f4<\/span><\/strong><\/h1>\n

The application scope of this Performance Qualification includes the <\/span>Agilent 1200 HPLC \uff08<\/span>Equipment ID:<\/span>zgb012<\/span>\uff09<\/span>in the QC of XXX Pharmaceutical Co., Ltd. System No.: SYM-QC-01-HPLC-<\/span>01<\/span>
\u672c\u6027\u80fd\u786e\u8ba4\u7684\u8303\u56f4\u4e3a<\/span>XXX\u8d28\u91cf\u63a7\u5236\u90e8\u7684Axxxxt\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\uff08\u8bbe\u5907\u7f16\u53f7\uff1a<\/span>xxxx<\/span>\uff09\uff0c\u7cfb\u7edf\u7f16\u53f7\u4e3a\uff1a<\/span>SYM-QC-<\/span>01-HPLC-xx<\/span>\u3002<\/span><\/p>\n

3. <\/span>Responsibility<\/span><\/strong>\u804c\u8d23<\/span><\/strong><\/h1>\n

XXX responsibility <\/span><\/strong>XXX\u7684\u804c\u8d23<\/span><\/span><\/strong><\/p>\n

\u00fc <\/span>I<\/span>Q Protocol Writing<\/span>
<\/span>\u7f16\u5236<\/span>IQ<\/span>\u65b9\u6848<\/span><\/p>\n

XXX<\/span><\/strong> responsibility<\/span><\/strong>xxxxx<\/span><\/strong>\u7684\u804c\u8d23<\/span><\/strong><\/p>\n

\u00fc <\/span>Review and approve this protocol before execution
\u6267\u884c\u524d\u5ba1\u6838\u548c\u6279\u51c6\u672c\u65b9\u6848<\/span><\/span><\/p>\n

\u00fc <\/span>Provide personnel, when necessary, to assist in the operation of equipment and system
\u5728\u9700\u8981\u7684\u65f6\u5019\uff0c\u63d0\u4f9b\u5fc5\u8981\u7684\u4eba\u5458\u534f\u52a9\u8fdb\u884c\u7cfb\u7edf\u548c\u8bbe\u5907\u7684\u8fd0\u884c<\/span><\/span><\/p>\n

\u00fc <\/span>Provide personnel, when necessary, to calibrate critical and non-critical measuring, recording, and\/or controlling instrumentation
\u5728\u9700\u8981\u7684\u65f6\u5019\uff0c\u63d0\u4f9b\u5fc5\u8981\u7684\u4eba\u5458\u8fdb\u884c\u6821\u51c6\u5173\u952e\u548c\u975e\u5173\u952e\u7684\u6d4b\u91cf\u3001\u8bb0\u5f55\u548c\u63a7\u5236\u4eea\u8868<\/span><\/span><\/p>\n

\u00fc <\/span>Provide calibration certificate of any instruments utilised during the execution of this Protocol<\/span>
<\/span>\u63d0\u4f9b\u5728\u65b9\u6848\u6267\u884c\u4e2d\u6240\u9700\u4eea\u5668\u7684\u6821\u51c6\u8bc1\u4e66<\/span><\/p>\n

\u00fc <\/span>Protocol execution<\/span> and <\/span>data collection<\/span>
<\/span>\u65b9\u6848\u7684\u5b9e\u65bd\uff0c\u6570\u636e\u7684\u6536\u96c6<\/span><\/p>\n

\u00fc <\/span>Define solution for non conformity
\u9488\u5bf9\u4e0d\u4e00\u81f4\u9879\u754c\u5b9a\u89e3\u51b3\u65b9\u6cd5<\/span><\/span><\/p>\n

\u00fc <\/span>Deviation report compilation<\/span>
<\/span>\u504f\u5dee\u62a5\u544a\u7684\u7f16\u5199<\/span><\/p>\n

\u00fc <\/span>Final <\/span>r<\/span>eport <\/span>compilation<\/span>
\u6700\u7ec8\u62a5\u544a\u7684\u7f16\u5199<\/span><\/p>\n

\u00fc <\/span>Review and approve the protocol and test reports after successful execution
\u5ba1\u6838\u548c\u6279\u51c6\u672c\u65b9\u6848\u548c\u6d4b\u8bd5\u62a5\u544a<\/span><\/span><\/p>\n

4. <\/span>Regulation and Guidance <\/span><\/strong>\u6cd5\u89c4\u548c\u6307\u5357<\/span><\/strong><\/h1>\n

To write this protocol have been used the following reference documents<\/span>:<\/span>
\u4e3a\u4e86\u7f16\u5199\u672c\u65b9\u6848\uff0c\u53c2\u8003\u4e86\u4ee5\u4e0b\u6587\u4ef6<\/span>\uff1a<\/span><\/p>\n

\u00fc <\/span>(SFDA) GMP (2010 Revision)<\/span>
<\/span><\/span>(SFDA) GMP(2010\u5e74\u4fee\u8ba2\u7248<\/span>)<\/span><\/span><\/p>\n

\u00fc <\/span>CP2015<\/span><\/p>\n

\u4e2d\u56fd\u836f\u5178<\/span>2015<\/span><\/p>\n


<\/span><\/p>\n

5. <\/span>Terms and Abbreviations<\/span><\/strong>\u672f\u8bed\u53ca\u7f29\u5199<\/span><\/strong><\/h1>\n\n\n\n\n\n\n\n\n\n
\n

Terms and Abbreviations<\/span><\/strong>\u672f\u8bed\u53ca\u7f29\u5199<\/span><\/strong><\/p>\n<\/td>\n

\n

Definition<\/span><\/strong>\u5b9a\u4e49<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

IQ<\/span><\/p>\n<\/td>\n

\n

Installation Qualification \u5b89\u88c5\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

OQ<\/span><\/p>\n<\/td>\n

\n

Operation Qualification \u8fd0\u884c\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

PQ<\/span><\/p>\n<\/td>\n

\n

Performance Qualification\u6027\u80fd\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

GMP<\/span><\/p>\n<\/td>\n

\n

Good Manufacturing Practice \u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

HPLC<\/span><\/p>\n<\/td>\n

\n

High-Performance Liquid Chromatography \u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

SOP<\/span><\/p>\n<\/td>\n

\n

Standard Operation Procedure\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

6. <\/span>System Description <\/span><\/strong>\u7cfb\u7edf\u63cf\u8ff0<\/span><\/strong><\/h1>\n

T<\/span>he Axxxx HPLC <\/span>\uff08<\/span>Equipment ID:<\/span>xxxx\uff09<\/span><\/span>in the QC of XXX Pharmaceutical Co., Ltd. System No.: SYM<\/span>-QC-01-HPLC-xx.
<\/span>XXX<\/span>\u8d28\u91cf\u63a7\u5236\u90e8\u7684<\/span>Axxxt  <\/span>\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\uff08\u8bbe\u5907\u7f16\u53f7\uff1a<\/span>xxx\uff09\uff0c\u7cfb\u7edf\u7f16\u53f7\u4e3a\uff1a<\/span>SYM-QC-01-HPLC-xx<\/span><\/span>\u3002<\/span><\/p>\n

T<\/span>he AXXXXX HPLC is composed of degasser, transfer pump, column heater, auto-sampler, detector and system software. <\/span>I<\/span>t is used for assay test, identification and impurity analysis.<\/span>
<\/span>\u8be5<\/span>Axxxx<\/span>\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\u7531\u8131\u6c14\u673a\uff0c\u8f93\u6db2\u6cf5\uff0c\u67f1\u6e29\u7bb1\uff0c\u81ea\u52a8\u8fdb\u6837\u5668\uff0c\u68c0\u6d4b\u5668\u53ca\u7cfb\u7edf\u8f6f\u4ef6\u7ec4\u6210\u3002<\/span>\u4e3b\u8981\u7528\u6765\u8fdb\u884c\u542b\u91cf\u6d4b\u5b9a\u3001\u9274\u522b\u3001\u53ca\u6742\u8d28\u5206\u6790\u3002<\/span><\/p>\n


<\/span><\/p>\n

7. <\/span>Documentation Control Specification \u6587\u4ef6\u7ba1\u7406\u89c4\u8303<\/span><\/span><\/strong><\/h1>\n

\u00fc <\/span>Recording pens \u8bb0\u5f55\u7528\u7b14\uff1a<\/span><\/span><\/p>\n

– Archive proof ink pens or marker pens shall be used. Blue pens are recommended.\u4f7f\u7528\u4e0d\u6d88\u9000\u7684\u58a8\u6c34\u7b14\u548c\u8bb0\u53f7\u7b14\uff0c\u63a8\u8350\u4f7f\u7528\u84dd\u8272\u7b14\u8bb0\u5f55<\/span><\/span><\/p>\n

\u00fc <\/span>Signature \u7b7e\u540d\uff1a<\/span><\/span><\/p>\n

– Only authorized persons can sign on any documents.\u88ab\u6388\u6743\u7684\u4eba\u5458\u624d\u80fd\u7b7e\u7f72\u6587\u4ef6<\/span><\/span><\/p>\n

– Unless otherwise specified, the full name shall be used as the signature..\u5e94\u7b7e\u5168\u540d\uff0c\u9664\u975e\u6587\u4ef6\u53e6\u6709\u89c4\u5b9a<\/span><\/span><\/p>\n

– The signature shall be readable.\u7b7e\u540d\u5e94\u8be5\u662f\u53ef\u8fa8\u8ba4\u7684<\/span><\/span><\/p>\n

– The signatures shall be consistent.\u7b7e\u540d\u5e94\u59cb\u7ec8\u4e00\u81f4<\/span><\/span><\/p>\n

\u00fc <\/span>Column filling \u586b\u5199\u680f\u76ee\uff1a<\/span><\/span><\/p>\n

– All the columns shall be filled.\u6240\u6709\u680f\u76ee\u5fc5\u987b\u586b\u5199<\/span><\/span><\/p>\n

– The full text shall be filled if it is the same as that in the field above.\u586b\u5199\u5185\u5bb9\u4e0e\u4e0a\u9762\u680f\u76ee\u76f8\u540c\u5e94\u91cd\u65b0\u586b\u5199<\/span><\/span><\/p>\n

– If there is nothing to be filled in to an individual field, N\/A (abbreviation for not applicable) shall be written in this field.\u82e5\u6709\u5355\u4e2a\u680f\u76ee\u4e0d\u9700\u8981\u586b\u5165\u5185\u5bb9\uff0c\u5219\u5728\u7a7a\u767d\u5904\u586b\u5199\u82f1\u6587\u5b57\u6bcd<\/span>\u201c\u4e0d\u9002\u7528<\/span>\u201d\u7684\u7b80\u5199<\/span>\u201cN\/A\u201d\uff0c\u4ee5\u8868\u793a\u65e0\u6b64\u9879\u5185\u5bb9\u3002<\/span><\/span><\/p>\n

– If there is nothing to be filled in more than one neighboring fields, such fields shall be crossed with a diagonal line, with \u201cN\/A\u201d 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.\u586b\u5199\u8bb0\u5f55\u65f6\uff0c\u82e5\u6709\u591a\u4e2a\u680f\u76ee\u4e0d\u9700\u8981\u586b\u5165\u5185\u5bb9\uff0c\u5e94\u7528\u659c\u7ebf\u5212\u6389\uff0c\u659c\u7ebf\u4e0a\u65b9\u586b\u5199<\/span>\u201cN\/A\uff0c\u4e0b\u65b9\u7b7e\u540d\u548c\u6ce8\u660e\u65e5\u671f\u3002\u7b7e\u540d\u53ca\u65e5\u671f\u5e94\u5c3d\u91cf\u6cbf\u659c\u7ebf\u540c\u4fa7\u586b\u5199\u3002<\/span><\/span><\/p>\n\n\n\n\n\n

<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n<\/tr>\n

<\/td>\n		\n

N\/A<\/span><\/p>\n<\/td>\n


<\/td>\n
<\/td>\n<\/tr>\n

<\/td>\n		\n

\u7b7e\u540d \u65e5\u671f<\/span><\/p>\n<\/td>\n

\n

Signature   date<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

\u00fc <\/span>Correction of mistakes \u66f4\u6539\u9519\u8bef\uff1a<\/span><\/span><\/p>\n

– 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. <\/span><\/p>\n

– <\/span><\/span>For example:     January 1, 2010,    signature and date<\/span><\/p>\n

\u6587\u4ef6\u521a\u5b8c\u6210\uff0c\u7acb\u5373\u66f4\u6539\u7684<\/span><\/p>\n

    \u5728\u9519\u8bef\u5904\u5212\u7ebf\uff0c<\/span> \u586b\u5165\u6b63\u786e\u7684\uff0c\u7b7e\u540d\u548c\u6ce8\u660e\u66f4\u6539\u65e5\u671f\uff0c\u786e\u4fdd\u539f\u5148\u4fe1\u606f\u4ecd\u6e05\u6670\u53ef\u8bc6\u522b\u3002<\/span><\/span><\/p>\n

<\/span>\u5982\uff1a<\/span>2010\u5e74<\/span>01\u6708<\/span>01\u65e5<\/span>   \u7b7e\u5b57\uff0c\u65e5\u671f<\/span><\/span><\/p>\n

– 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.<\/span>
<\/span>\u4e8b\u540e\u66f4\u6539\u7684\uff0c\u9664\u975e\u7acb\u5373\u66f4\u6539\u7684\u8981\u6c42\u5916\uff0c\u8fd8\u5e94\u6ce8\u660e\u66f4\u6539\u7684\u539f\u56e0\uff0c\u68c0\u67e5\u548c\u6ce8\u91ca\u53ef\u80fd\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\u00fc <\/span>Date Recording Format \u8bb0\u5f55\u65e5\u671f\uff1a<\/span><\/span><\/p>\n

– Four digits shall be used for the indication of the year, two digits for the month and another two for the date. \u5e74\u7528<\/span>4\u4f4d\u6570\u8868\u793a\uff0c\u65e5\u548c\u6708\u7528<\/span>2\u4f4d\u6570\u8868\u793a<\/span><\/span><\/p>\n

For example: 20<\/span>10<\/span>.0<\/span>1<\/span>.01 <\/span><\/p>\n

\u5982\uff1a<\/span>20<\/span>10<\/span>.0<\/span>1<\/span>.01<\/span><\/p>\n

\u00fc <\/span>Use of Abbreviations \u4f7f\u7528\u7f29\u7565\u8bed\uff1a<\/span><\/span><\/p>\n

– An abbreviation shall be noted in brackets immediately after the full name before it can be used in the rest of the document.\u5728\u672f\u8bed\u5168\u79f0\u540e\u7684\u62ec\u53f7\u5185\u6ce8\u660e\u7f29\u5199\uff0c\u7136\u540e\u624d\u53ef\u4ee5\u4f7f\u7528\u7f29\u5199\u3002<\/span><\/span><\/p>\n

\u00fc <\/span>Written Words and Names \u4e66\u9762\u8bed\u53ca\u540d\u79f0\uff1a<\/span><\/span><\/p>\n

– Standard written words and names shall be used.\u4f7f\u7528\u89c4\u8303\u7684\u4e66\u9762\u8bed\u53ca\u540d\u79f0<\/span><\/span><\/p>\n

– The names shall be consistent all through the document.\u6587\u4ef6\u524d\u540e\u540d\u79f0\u8981\u4e00\u81f4<\/span><\/span><\/p>\n


<\/span><\/p>\n

8. <\/span>Test List\u6d4b\u8bd5\u9879\u76ee\u5217\u8868<\/span><\/span><\/strong><\/h1>\n

The test which will be performed in this protocol, are listed in the following form.
\u5728\u4e0b\u9762\u7684\u8868\u683c\u5217\u51fa\u4e86\u672c\u65b9\u6848\u5c06\u8981\u6267\u884c\u7684\u6d4b\u8bd5\u3002<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n\n
\n

Test .No.
\u7f16\u53f7<\/span><\/p>\n<\/td>\n

\n

Test Name
\u540d\u79f0<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

9.1<\/span><\/p>\n<\/td>\n

\n

Personal Qualification<\/span>
<\/span>\u4eba\u5458\u7684\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

9.2<\/span><\/p>\n<\/td>\n

\n

Prerequisites<\/span>
<\/span>\u5148\u51b3\u6761\u4ef6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

9.3<\/span><\/p>\n<\/td>\n

\n

Module Qualification<\/span>
<\/span>\u6a21\u5757\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

9.4<\/span><\/p>\n<\/td>\n

\n

Module Accessories Qualification<\/span>
<\/span>\u6a21\u5757\u9644\u4ef6\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

9.5<\/span><\/p>\n<\/td>\n

\n

Module Installation Qualification
\u6a21\u5757\u5b89\u88c5\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

9.<\/span>6<\/span><\/p>\n<\/td>\n

\n

Software Version Controlling<\/span>
<\/span>\u8f6f\u4ef6\u7248\u672c\u63a7\u5236<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/span><\/p>\n

9. <\/span>Test Description and Acceptance Criteria \u6d4b\u8bd5\u63cf\u8ff0\u548c\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/span><\/strong><\/h1>\n

9.1 <\/span>Personal <\/span><\/strong>Qualification<\/span><\/strong>\u4eba\u5458\u7684<\/span><\/strong>\u786e\u8ba4<\/span><\/strong><\/h2>\n

Purpose <\/span><\/em>\u76ee\u7684<\/span><\/em><\/p>\n

Identify all people involve in protocol execution.
\u786e\u8ba4\u6240\u6709\u5728\u6267\u884c\u672c\u65b9\u6848\u7684\u4eba\u5458\u7684\u8d44\u683c\u3002<\/span><\/span><\/p>\n

Procedure<\/span><\/em>\u7a0b\u5e8f<\/span><\/em><\/p>\n

List and identify all personnel involved in the execution of the present protocol (Name. Signature, Initials and Department\/Company).<\/span>
<\/span>\u5217\u51fa\u548c\u786e\u8ba4\u6240\u6709\u5728\u6267\u884c\u672c\u65b9\u6848\u7684\u4eba\u5458\uff08\u59d3\u540d\u3001\u7b7e\u540d\u3001\u7f29\u5199\u548c\u90e8\u95e8<\/span>\/\u516c\u53f8\uff09\u3002 <\/span><\/span><\/p>\n

Acceptance Criteria<\/span><\/em>\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/p>\n

All the operators are identified by Name, Signature, Initials and Department\/Company<\/span>.<\/span>
\u6240\u6709\u5728\u6267\u884c\u672c\u65b9\u6848\u7684\u4eba\u5458\uff08\u59d3\u540d\u3001\u7b7e\u540d\u3001\u7f29\u5199\u548c\u90e8\u95e8<\/span>\/\u516c\u53f8\uff09\u5df2\u786e\u8ba4<\/span><\/span>\u3002<\/span><\/p>\n

Test Report<\/span><\/em>\u6d4b\u8bd5\u62a5\u544a<\/span><\/em><\/p>\n

Fill in Test Report No.1.
\u586b\u5199<\/span><\/span>\u201c<\/span>\u6d4b\u8bd5\u62a5\u544a<\/span>1<\/span>\u201d<\/span>\u3002<\/span><\/p>\n

9.2 <\/span>Prerequisites<\/span><\/strong>\u5148\u51b3\u6761\u4ef6<\/span><\/strong><\/h2>\n

Purpose <\/span><\/em>\u76ee\u7684<\/span><\/em><\/p>\n

All prerequisites necessary to the <\/span>PQ <\/span>execution have been satisfied.<\/span>
<\/span>\u6240\u6709\u8fdb\u884c<\/span>\u6027\u80fd<\/span>\u786e\u8ba4\u7684\u5148\u51b3\u6761\u4ef6\u5df2\u7ecf\u5f97\u5230\u6ee1\u8db3\u3002<\/span><\/p>\n

Procedure<\/span><\/em>\u7a0b\u5e8f<\/span><\/em><\/p>\n

The installation of the HPLC has been finished.<\/span><\/p>\n

\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\u5df2\u5b8c\u6210\u5b89\u88c5\u3002<\/span><\/p>\n

Verify that <\/span>I<\/span>Q protocol has been approved.<\/span>
<\/span>\u786e\u8ba4\u672c<\/span>\u5b89\u88c5\u786e\u8ba4<\/span>\u65b9\u6848\u5df2\u5f97\u5230\u6279\u51c6\u3002<\/span><\/p>\n

There should be a documented training for all people involved in the tests before initiation of <\/span>I<\/span>Q.
\u5728<\/span><\/span>I<\/span>Q\u5f00\u59cb\u524d\uff0c\u5bf9\u6240\u6709\u53c2\u4e0e\u6d4b\u8bd5\u7684\u4eba\u5458\u8fdb\u884c\u65b9\u6848\u7684\u57f9\u8bad\u3002\u57f9\u8bad\u5e94\u8be5\u6709\u8bb0\u5f55\u3002<\/span><\/span><\/p>\n

Acceptance Criteria<\/span><\/em>\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/p>\n

All the prerequisites must be satisfied before the beginning of the execution of IQ test.<\/span>
<\/span>\u5f00\u59cb\u6267\u884c\u672c\u6d4b\u8bd5\u4e4b\u524d\uff0c\u6240\u6709\u7684\u5148\u51b3\u6761\u4ef6\u5fc5\u987b\u5f97\u5230\u6ee1\u8db3\u3002<\/span><\/p>\n

Test Report<\/span><\/em>\u6d4b\u8bd5\u62a5\u544a<\/span><\/em><\/p>\n

Fill in Test Report No.2.
\u586b\u5199<\/span><\/span>\u201c<\/span>\u6d4b\u8bd5\u62a5\u544a<\/span>2<\/span>\u201d<\/span>\u3002<\/span> <\/span><\/p>\n

9.3 <\/span>Module Qualification\u6a21\u5757\u786e\u8ba4<\/span><\/span><\/strong><\/h2>\n

Purpose <\/span><\/em>\u76ee\u7684<\/span><\/em><\/p>\n

T<\/span>his test is to verify the consistency between the module list and site module.<\/span>
<\/span>\u8be5\u6d4b\u8bd5\u7528\u4ee5\u786e\u8ba4\u6a21\u5757\u6e05\u5355\u4e0e\u73b0\u573a\u6a21\u5757\u7684\u4e00\u81f4\u6027\u3002<\/span><\/p>\n

Procedure<\/span><\/em>\u7a0b\u5e8f<\/span><\/em><\/p>\n

R<\/span>efer to the module list to verify the site module and record the type.<\/span>
<\/span>\u6839\u636e\u6a21\u5757\u6e05\u5355\uff0c\u6838\u5b9e\u73b0\u573a\u6a21\u5757\uff0c\u5e76\u8bb0\u5f55\u5176\u578b\u53f7\u3002<\/span><\/p>\n

M<\/span>odule list includes quaternary pump module, auto-sampler module, ultraviolet detector module and column heater module.<\/span>
<\/span>\u6a21\u5757\u6e05\u5355\u5185\u5305\u542b\uff1a\u56db\u5143\u6cf5\u6a21\u5757\u3001\u81ea\u52a8\u8fdb\u6837\u5668\u6a21\u5757\u3001\u7d2b\u5916\u68c0\u6d4b\u5668\u6a21\u5757\u3001\u67f1\u6e29\u7bb1\u6a21\u5757\u3002<\/span><\/p>\n

Acceptance Criteria<\/span><\/em>\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/p>\n

T<\/span>he module list should conform to site module, and record the type.<\/span>
<\/span>\u6a21\u5757\u6e05\u5355\u5e94\u4e0e\u73b0\u573a\u6a21\u5757\u4e00\u81f4\uff0c\u578b\u53f7\u5df2\u8bb0\u5f55\u3002<\/span><\/p>\n

Test Report<\/span><\/em>\u6d4b\u8bd5\u62a5\u544a<\/span><\/em><\/p>\n

Fill in Test Report No.<\/span>3<\/span>.
\u586b\u5199<\/span><\/span>\u201c<\/span>\u6d4b\u8bd5\u62a5\u544a<\/span>3\u201d<\/span><\/span>\u3002<\/span><\/p>\n

9.4 <\/span>Module Accessories Qualification\u6a21\u5757\u9644\u4ef6\u786e\u8ba4<\/span><\/span><\/strong><\/h2>\n

Purpose <\/span><\/em>\u76ee\u7684<\/span><\/em><\/p>\n

T<\/span>his test is to verify the integration of each module accessories and relevant <\/span>manual<\/span>.<\/span>
<\/span>\u8be5\u6d4b\u8bd5\u7528\u4ee5\u786e\u8ba4\u5404\u6a21\u5757\u9644\u4ef6\u53ca\u5176\u76f8\u5173\u624b\u518c\u7684\u5b8c\u6574\u6027\u3002<\/span><\/p>\n

Procedure<\/span><\/em>\u7a0b\u5e8f<\/span><\/em><\/p>\n

Check the integration of each component accessories and <\/span>relevant<\/span> manual.<\/span>
<\/span>\u6838\u5b9e\u5404\u7ec4\u4ef6\u9644\u4ef6\u53ca\u5176\u624b\u518c\u7684\u5b8c\u6574\u6027\u3002<\/span><\/p>\n

Pump\uff1a<\/span>Operating <\/span><\/span>Manual, Power<\/span> Cord,<\/span> LAN cable<\/span>
\u6cf5\uff1a\u64cd\u4f5c\u624b\u518c\uff0c\u7535\u6e90\u7ebf\uff0c<\/span>Lan\u7535\u7f06<\/span><\/span><\/p>\n

Auto-sampler\uff1a<\/span>Operating <\/span><\/span>Manual, Power<\/span> Cord,<\/span> LAN cable, 100ml<\/span> <\/span>Rhoedyne<\/span> ,Package 200\u00d7<\/span>2ml Vials<\/span><\/span>
<\/span>\u81ea\u52a8\u8fdb\u6837\u5668\uff1a\u64cd\u4f5c\u624b\u518c\uff0c\u7535\u6e90\u7ebf\uff0c<\/span>Lan\u7535\u7f06 \uff0c<\/span>100ml<\/span>\u5b9a\u91cf\u73af\uff0c\u4e00\u76d2<\/span>200<\/span>\u00d7<\/span>2ml<\/span>\u8fdb\u6837\u74f6<\/span><\/span><\/p>\n

Column heater\uff1a<\/span>Operating <\/span><\/span>Manual, Power<\/span> Cord,<\/span> LAN cable<\/span>
\u67f1\u6e29\u7bb1\uff1a\u64cd\u4f5c\u624b\u518c\uff0c\u7535\u6e90\u7ebf\uff0c<\/span>Lan\u7535\u7f06<\/span><\/span><\/p>\n

Detector\uff1a<\/span>Operating <\/span><\/span>Manual, Power<\/span> Cord,<\/span> LAN cable, <\/span>UV <\/span>Lamp<\/span>
\u68c0\u6d4b\u5668\uff1a\u64cd\u4f5c\u624b\u518c\uff0c\u7535\u6e90\u7ebf\uff0c<\/span>Lan\u7535\u7f06\uff0c\u7d2b\u5916\u706f<\/span><\/span><\/p>\n

Acceptance Criteria<\/span><\/em>\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/p>\n

Each module accessories and relevant files are integral.<\/span>
<\/span>\u5404\u6a21\u5757\u9644\u4ef6\u53ca\u5176\u76f8\u5173\u6587\u4ef6\u5e94\u5b8c\u6574\u3002<\/span><\/p>\n

Test Report<\/span><\/em>\u6d4b\u8bd5\u62a5\u544a<\/span><\/em><\/p>\n

Fill in Test Report No.<\/span>4<\/span>.
\u586b\u5199<\/span><\/span>\u201c<\/span>\u6d4b\u8bd5\u62a5\u544a<\/span>4\u201d<\/span><\/span>\u3002<\/span> <\/span><\/p>\n

9.5 <\/span>Module Installation Qualification\u6a21\u5757\u5b89\u88c5\u786e\u8ba4<\/span><\/span><\/strong><\/h2>\n

Purpose <\/span><\/em>\u76ee\u7684<\/span><\/em><\/p>\n

T<\/span>his test is to verify the module has been installed normally.<\/span>
<\/span>\u8be5\u6d4b\u8bd5\u7528\u4ee5\u786e\u8ba4\u6a21\u5757\u5df2\u7ecf\u6b63\u5e38\u5b89\u88c5\u3002<\/span><\/p>\n

Procedure<\/span><\/em>\u7a0b\u5e8f<\/span><\/em><\/p>\n

T<\/span>he width and <\/span>depth<\/span> of each module is suitable to complete the installation properly.<\/span>
<\/span>\u5404\u6a21\u5757\u7684\u5bbd\u5ea6\u4e0e\u6df1\u5ea6\u5408\u9002\uff0c\u53ef\u4ee5\u6b63\u786e\u5b89\u88c5\u3002<\/span><\/p>\n

D<\/span>etector flow cell and UV lamp are easy to dismount. <\/span>
<\/span>\u68c0\u6d4b\u5668\u6d41\u901a\u6c60\u548c\u7d2b\u5916\u706f\u5e94\u6613\u62c6\u5378\u3002<\/span><\/p>\n

P<\/span>ump, auto-sampler, column heater and detector unit are started normally, and the power button will indicate open status. <\/span>T<\/span>he corresponding part on software controlling interface will show be usable.<\/span>
<\/span>\u6cf5\u3001\u81ea\u52a8\u8fdb\u6837\u5668\u3001\u67f1\u6e29\u7bb1\u3001\u68c0\u6d4b\u5668\u5355\u5143\u53ef\u6b63\u5e38\u542f\u52a8\uff0c\u7535\u6e90\u952e\u5e94\u663e\u793a\u5f00\u542f\u72b6\u6001\uff0c\u8f6f\u4ef6\u63a7\u5236\u754c\u9762\u76f8\u5e94\u5355\u5143\u90e8\u5206\u663e\u793a\u53ef\u7528\u3002<\/span><\/p>\n

Acceptance Criteria<\/span><\/em>\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/p>\n

E<\/span>ach module has been installed properly and is usable.<\/span>
<\/span>\u5404\u6a21\u5757\u5df2\u7ecf\u6b63\u786e\u5b89\u88c5\uff0c\u5e76\u4e14\u53ef\u7528\u3002<\/span><\/p>\n

Test Report<\/span><\/em>\u6d4b\u8bd5\u62a5\u544a<\/span><\/em><\/p>\n

Fill in Test Report No.<\/span>5<\/span>.
\u586b\u5199<\/span><\/span>\u201c<\/span>\u6d4b\u8bd5\u62a5\u544a<\/span>5\u201d<\/span><\/span>\u3002<\/span><\/p>\n

9.6 <\/span>Software Version Controlling\u8f6f\u4ef6\u7248\u672c\u63a7\u5236<\/span><\/span><\/strong><\/h2>\n

Purpose <\/span><\/em>\u76ee\u7684<\/span><\/em><\/p>\n

This test is to verify the operating software version. <\/span>
<\/span>\u8be5\u6d4b\u8bd5\u7528\u4ee5\u786e\u8ba4\u64cd\u4f5c\u8f6f\u4ef6\u7684\u7248\u672c\u3002<\/span><\/p>\n

Procedure<\/span><\/em>\u7a0b\u5e8f<\/span><\/em><\/p>\n

Record the current software version and verify the installation CD is readable.
\u8bb0\u5f55\u5f53\u524d\u8f6f\u4ef6\u7248\u672c\u5e76\u786e\u8ba4\u5b89\u88c5\u5149\u76d8\u53ef\u8bfb\u3002<\/span><\/span><\/p>\n

Acceptance Criteria<\/span><\/em>\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/p>\n

S<\/span>oftware version has been recorded, and the installation CD is readable and preserved properly. <\/span>
<\/span>\u8f6f\u4ef6\u7248\u672c\u5df2\u8bb0\u5f55\uff0c\u5b89\u88c5\u5149\u76d8\u53ef\u6253\u5f00\u5e76\u5df2\u7ecf\u59a5\u5584\u4fdd\u5b58\u3002<\/span><\/p>\n

Test Report<\/span><\/em>\u6d4b\u8bd5\u62a5\u544a<\/span><\/em><\/p>\n

Fill in Test Report No.<\/span>6<\/span>.
\u586b\u5199<\/span><\/span>\u201c<\/span>\u6d4b\u8bd5\u62a5\u544a<\/span>6\u201d<\/span><\/span>\u3002<\/span><\/p>\n

 <\/span><\/p>\n

10. <\/span>Deviation Report<\/span><\/strong>\u504f\u5dee\u62a5\u544a<\/span><\/strong><\/h1>\n

Any deviation<\/span>s<\/span> found <\/span>during<\/span> execution <\/span>of this protocol <\/span>will be handled according to the SOP for Deviation Management of <\/span>XXX<\/span>. Each deviation will be given a unique number and record<\/span>ed<\/span> in the deviation report. <\/span>The <\/span>deviations <\/span>will be summarized <\/span>in the deviation list.
\u6d4b\u8bd5\u8fc7\u7a0b\u4e2d\u53d1\u751f\u7684\u4efb\u4f55\u504f\u5dee\u90fd\u5c06\u4f9d\u636e<\/span><\/span>xxxx<\/span>\u7684\u504f\u5dee\u7ba1\u7406<\/span>SOP\u5904\u7406\u3002\u6bcf\u4e2a\u504f\u5dee\u90fd\u8981\u7ed9\u4e88\u4e00\u4e2a\u552f\u4e00\u7684\u7f16\u53f7\u5e76\u8bb0\u5f55\u5728\u504f\u5dee\u62a5\u544a\u91cc\u3002\u5728\u504f\u5dee\u6e05\u5355\u4e2d\uff0c\u6c47\u603b\u6240\u6709\u7684\u504f\u5dee\u3002<\/span><\/span><\/p>\n

Use cop<\/span>ies<\/span> of <\/span>the <\/span>deviation report if necessary.
\u5982\u6709\u9700\u8981\u53ef\u590d\u5370\u504f\u5dee\u62a5\u544a\u3002<\/span><\/span><\/p>\n

11. <\/span>List of Deviation <\/span><\/strong>\u504f\u5dee\u6e05\u5355<\/span><\/strong><\/h1>\n

Record in the test report <\/span>7<\/span> all deviations found during<\/span> P<\/span>Q activities and indicate solution date.
\u5728\u6d4b\u8bd5\u62a5\u544a<\/span><\/span>7<\/span>\u4e2d\u8bb0\u5f55\u6240\u6709\u7684\u5728\u6267\u884c<\/span>P<\/span>Q\u6d3b\u52a8\u4e2d\u53d1\u751f\u7684\u504f\u5dee\uff0c\u5e76\u6ce8\u660e\u89e3\u51b3\u65e5\u671f\u3002<\/span><\/span><\/p>\n

Use additional pages as required, Number the pages used.
\u5982\u679c\u9700\u8981\u53ef\u4ee5\u52a0\u9875\uff0c\u9700\u5bf9\u4f7f\u7528\u7684\u9875\u8fdb\u884c\u7f16\u53f7\u3002<\/span><\/span><\/p>\n

12. <\/span>List of Attachment<\/span><\/strong>\u9644\u4ef6\u6e05\u5355<\/span><\/strong><\/h1>\n

Record in the test report <\/span>8<\/span> all documents attached to this protocol indicating the number and the title of relevant test report.
\u5728\u6d4b\u8bd5\u62a5\u544a<\/span><\/span>8<\/span>\u4e2d\u8bb0\u5f55\u6240\u6709\u9644\u5728\u672c\u65b9\u6848\u4e2d\u7684\u6587\u4ef6\uff0c\u6ce8\u660e\u9875\u6570\u548c\u76f8\u5173\u7684\u6d4b\u8bd5\u62a5\u544a\u3002<\/span><\/p>\n

Use additional pages as required, Number the pages used.
\u5982\u679c\u9700\u8981\u53ef\u4ee5\u52a0\u9875\uff0c\u9700\u5bf9\u4f7f\u7528\u7684\u9875\u8fdb\u884c\u7f16\u53f7\u3002<\/span><\/span><\/p>\n

13. <\/span>Change Control<\/span><\/strong>\u53d8\u66f4<\/span><\/strong>\u63a7\u5236<\/span><\/strong><\/h1>\n

Any changed of the system will be submitted to a Change Control Procedure, in accordance with according to the SOP for Change Control<\/span> of XXX<\/span>. All<\/span> <\/span>Change Control Forms for the system will be filed<\/span>.<\/span>
\u7cfb\u7edf\u4efb\u4f55\u7684<\/span>\u53d8\u66f4<\/span>\u5e94\u6309\u7167<\/span>\u77f3\u5bb6\u5e84\u56db\u836f<\/span>\u7684<\/span>\u53d8\u66f4\u63a7\u5236<\/span>SOP <\/span>\u5904\u7406<\/span>\uff0c\u6240\u6709<\/span>\u53d8\u66f4\u63a7\u5236\u8868<\/span>\u5c06\u88ab\u6536\u96c6\u3002<\/span><\/p>\n

14. <\/span>Execution Review and Approval<\/span><\/strong>\u6267\u884c\u7684\u5ba1\u6838\u548c\u6279\u51c6<\/span><\/strong><\/h1>\n

To conclude the performance of <\/span>P<\/span>Q and approval of the report.
\u5bf9<\/span><\/span>\u6027\u80fd<\/span>\u786e\u8ba4\u7684\u6267\u884c\u8fc7\u7a0b\u8fdb\u884c\u603b\u7ed3\u5e76\u5bf9\u62a5\u544a\u8fdb\u884c\u5ba1\u6279\u3002<\/span><\/p>\n

Record in the test report <\/span>9.<\/span>
\u586b\u5199\u6d4b\u8bd5\u62a5\u544a<\/span>9\u3002<\/span><\/span><\/p>\n


<\/span><\/p>\n

15. <\/span>Index of Test Report \u6d4b\u8bd5\u62a5\u544a\u76ee\u5f55<\/span><\/span><\/strong><\/h1>\n

 <\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Index<\/span><\/p>\n

\u76ee\u5f55<\/span><\/p>\n<\/td>\n

\n

Description<\/span><\/p>\n

\u63cf\u8ff0<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a1<\/span><\/p>\n<\/td>\n

\n

Personnel Qualification<\/span>
<\/span>\u4eba\u5458\u7684\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a2<\/span><\/p>\n<\/td>\n

\n

Prerequisites<\/span>
<\/span>\u5148\u51b3\u6761\u4ef6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a3<\/span><\/p>\n<\/td>\n

\n

Module Qualification<\/span>
<\/span>\u6a21\u5757\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a4<\/span><\/p>\n<\/td>\n

\n

Module Accessories Qualification<\/span>
<\/span>\u6a21\u5757\u9644\u4ef6\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a5<\/span><\/p>\n<\/td>\n

\n

Module Installation Qualification
\u6a21\u5757\u5b89\u88c5\u786e\u8ba4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a6<\/span><\/p>\n<\/td>\n

\n

Software Version Controlling<\/span>
<\/span>\u8f6f\u4ef6\u7248\u672c\u63a7\u5236<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a7<\/span><\/p>\n<\/td>\n

\n

List of Deviations<\/span>
<\/span>\u504f\u5dee\u6e05\u5355<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a8<\/span><\/p>\n<\/td>\n

\n

List of Attachment<\/span>
<\/span>\u9644\u4ef6\u6e05\u5355<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Test Report\u6d4b\u8bd5\u62a5\u544a<\/span>9<\/span><\/p>\n<\/td>\n

\n

Execution Review and Approval<\/span>
<\/span>\u6267\u884c\u7684\u5ba1\u6838\u548c\u62a5\u544a\u7684\u6279\u51c6<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                      <\/span><\/p>\n

\u25bc<\/span><\/strong><\/p>\n

\u671b \u60a8 \u5173 \u6ce8<\/strong><\/span><\/p>\n

\"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/p>\n

\"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span> \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span> \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span> \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span> \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span> \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span> \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span> \"\u597d\u6d88\u606f\uff01\u300aHPLC\u786e\u8ba4IQ\/OQ\/PQ\u65b9\u6848\/\u62a5\u544a\u300b\uff08\u6b27\u76df\/FDA<\/span>
<\/p>\n

\u5236\u836f\u5de5\u7a0b\u8bba\u575b\uff08CSPE\uff09\uff0c\u6280\u672f\u77e5\u8bc6\u3001\u4ea4\u6d41\u793e\u533a\u3001\u804c\u4e1a\u53d1\u5c55\u7b49\u533b\u836f\u65b0\u5a92\u4f53\u5e73\u53f0\uff0c \u4e3a\u4e2d\u56fd\u7684\u5236\u836f\u5de5\u7a0b\u4ece\u4e1a\u4eba\u58eb\u63d0\u4f9b\u6700\u5168\u9762\u4e14\u4e13\u4e1a\u7684\u8d44\u8baf\uff0c\u4e0e\u4e2d\u56fd\u540c\u884c\u4e00\u8d77\u4fc3\u8fdb\u5236\u836f\u884c\u4e1a\u7684\u5065\u5eb7\u53d1\u5c55\u3002\u5236\u836f\u5de5\u7a0b\u8bba\u575b\u8054\u5408\u591a\u540d\u6765\u81ea\u5168\u7403\u5236\u836f\u884c\u4e1a\u53d1\u8fbe\u56fd\u5bb6\u7684GxP\u4e13\u5bb6\uff0c\u4ee5\u53ca\u56fd\u5185\u77e5\u540dGMP\u4e13\u5bb6\u548c\u56fd\u9645\u6ce8\u518c\u987e\u95ee\u3002\u4ee5\u5168\u7403\u6700\u65b0\u6cd5\u89c4\u6307\u5357\u4f5c\u4e3a\u5f15\u9886\uff0c\u4ee5\u4e3a\u5236\u836f\u8d28\u91cf\u4f53\u7cfb\u4e3a\u4e2d\u5fc3\uff0c\u901a\u8fc7\u5f3a\u6709\u529b\u7684\u9879\u76ee\u7ba1\u7406\u56e2\u961f\uff0c\u4e3a\u5236\u836f\u884c\u4e1a\u63d0\u4f9b\u7b26\u5408FDA\u3001EMA\u3001CFDA\u3001MHRA\u3001PIC\/S\u3001WHO\u7b49\u8981\u6c42\u7684GxP\u5408\u89c4\u670d\u52a1\u3002\u672c\u7740\u4ee5\u5ba2\u6237\u4e3a\u4e2d\u5fc3\u7684\u7406\u5ff5\uff0c\u4ece\u7814\u53d1\u8d28\u91cf\u4f53\u7cfb\u54a8\u8be2\u3001\u6280\u672f\u8f6c\u79fb\u54a8\u8be2\u3001\u9a8c\u8bc1\u54a8\u8be2\u4e0e\u6d4b\u8bd5\u3001\u6570\u636e\u53ef\u9760\u6027\u54a8\u8be2\u3001\u8d28\u91cf\u4f53\u7cfb\u54a8\u8be2\u3001\u5de5\u827a\u5f00\u53d1\u54a8\u8be2\u3001\u8fd0\u884c\u5353\u8d8a\u54a8\u8be2\u3001\u6ce8\u518c\u62a5\u6279\u4ee5\u53ca\u57f9\u8bad\u7b49\u65b9\u9762\u4e3a\u5236\u836f\u884c\u4e1a\u63d0\u4f9b\u6db5\u76d6\u836f\u54c1\u751f\u547d\u5468\u671f\u548c\u6cd5\u89c4\u6027\u54a8\u8be2\u670d\u52a1\u3002<\/span><\/p>\n

<\/span><\/p>\n

\n

\u957f\u6309\u4e8c\u7ef4\u7801\u8bc6\u522b\u516c\u4f17\u53f7<\/span><\/p>\n

\n
\n


<\/p>\n

\n
\n
\n
\n

\u514d\u8d23\u58f0\u660e\uff1a\u7f16\u8f91\u5bf9\u4e0a\u8ff0\u5185\u5bb9\uff0c\u5bf9\u6587\u4e2d\u9648\u8ff0\u3001\u89c2\u70b9\u5224\u65ad\u4fdd\u6301\u4e2d\u7acb\uff0c\u4e0d\u5bf9\u6240\u5305\u542b\u5185\u5bb9\u7684\u51c6\u786e\u6027\u3001\u53ef\u9760\u6027\u6216\u5b8c\u6574\u6027\u63d0\u4f9b\u4efb\u4f55\u660e\u793a\u6216\u6697\u793a\u7684\u4fdd\u8bc1\u3002\u4ec5\u4f5c\u53c2\u8003\uff0c\u5e76\u8bf7\u5404\u4f4d\u81ea\u884c\u627f\u62c5\u5168\u90e8\u8d23\u4efb\u3002\u672c\u6587\u8f6c\u8f7d\u4ec5\u4e3a\u4ea4\u6d41\u5b66\u4e60\uff0c\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\uff0c<\/span>\u5982\u9047\u7248\u6743\u95ee\u9898\u8bf7\u8054\u7cfb\u5c0f\u7f16\u5220\u9664\u3002<\/span><\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5236\u836f\u5de5\u7a0b\u8bba\u575b <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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