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1、百奧泰生物科技(廣州)有限公司Bio-ThreaSolutions.Ltd.XXXXXXXXXXXXX(小四,黑體加粗。其余五號黑體加粗))編號/DocNo.:SOP-XXXXXXXXXX版本號/RevisionNO.:00XXXXXXXXXXXXX(小二,宋體加粗,居中)DocumentName(小二,Arial加粗,居中)文件隸屬部門/Dept.:XXXXXXXXXXXX(小四宋體、Arial,加粗,居中)生效日期:ValidSince年/Year月/Month日/Day(小四宋體、Arial,加粗,居中)分發(fā)部門/DistributionDepartment(小四宋體、Arial,
2、加粗,居中)部門Department職位Position姓名Name簽名Signature日期Date起草人PreparedbyXXXXXXXXX審核人CheckedbyXXXXXXXXX審核人CheckedbyXXXXXXXXX審核人CheckedbyXXXXXXXXX審核人CheckedbyXXXXXXXXX批準(zhǔn)人ApprovedbyXXX(小四宋體、Arial,加粗,居中)第3頁共3頁百奧泰生物科技(廣州)有限公司Bio-ThreaSolutions.Ltd.XXXXXXXXXXXXX(小四,黑體加粗。其余五號黑體加粗))編號/DocNo.:SOP-XXXXXXXXXX版本號/Re
3、visionNO.:001.目的Objective(宋體,小四加粗)XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX。(正文首行空兩格,中文宋體,字母Arial,小四)2.適用范圍ApplicablescopeXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX(文件適用的范圍)。3.責(zé)任Responsibilities3.1.XXXXX
4、XXXXXXXXXXXXXXXXXXX。(此文件對各部門的要求)3.2.XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX。4.縮略語及定義Abbreviationanddefinitions4.1.XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX。(文件中提到的任何專業(yè)名詞或縮略詞)4.2.XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.5.規(guī)程Procedure(文件內(nèi)容)5.1.XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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6、XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX。6.附件Annexes(文件中的流程圖、圖等附錄,文件涉及的記錄)第3頁共3頁百奧泰生物科技(廣州)有限公司Bio-ThreaSolutions.Ltd.XXXXXXXXXXXXX(小四,黑體加粗。其余五號黑體加粗))編號/DocNo.:SOP-XXXXXXXXXX版本號/RevisionNO.:001.1.XXXXXXX[SOP-XX-XXX-XX-FXX]1.2.XXXXXXXXXXX[SOP-XX-XXX-XX-RXX]1.3.XXXXXXXXXXX[SOP-XX-XXX-XX-RXX]2.涉及文件RelatedDocu
7、ments(此文件相關(guān)的其他GMP文件)2.1.XXXXXXXXXXXXXX[SOP-XX-XXX]2.2.XXXXXXXXXXXXXX[SOP-XX-XXX]2.3.XXXXXXXXXXXXXX[SOP-XX-XXX]3.參考文獻(xiàn)References(起草此文件參考的法規(guī)指南文件)3.1.《XXXXXXXXXXXXXXXXXXXXXX》3.2.《XXXXXXXXXXXXXXXXXXXXXXXXXXX》3.3.“XXXXXXXXXX