世界顶级制药公司验证文本模板.doc

INSTALLATION QUALIFICATION/ OPERATIONAL QUALIFICATION/ PERFORMANCE QUALIFICATION PROTOCOL (IQOQPQP) FOR System Name Version: 1.0 Date of Version: DD-MMM-YYYY Document ID: NJxxxxxx-xxx ///The document ID naming convention is governed by GMP 110.46. Please refer to GMP 110.46 or contact the NJ Validation Documentation Library for assistance/// /// THIS PAGE MUST BE DELETED BEFORE PUBLICATION (IQOQPQP Version C) The purpose of this template is to assist in the interpretation, application, and preparation of the Installation Qualification/ Operational Qualification/ Performance Qualification Protocol according to the NJ Site guidelines and the xxxxxxxxx. Paragraphs in blue italics font are meant to serve as instructions to the Author and should be deleted in the final document. Paragraphs in black regular font are sample wording that may be used as is or modified as needed. Should a paragraph not be applicable, delete it from the document altogether. Red text indicates example text, which may be used if applicable. If red text does apply to your system/project, keep the text and convert the text color to black. Should the red text not be applicable, delete it from the document altogether Green text indicates sections of the document that may be deleted. If these sections do not apply, you may remove them. If a green section does apply to your system/project keep the section and convert the section text color to black. No sections, other than the green sections as mentioned above, may be deleted from the document. If a section does not apply, the section heading must remain and a statement of non-applicability must be added under that section. Text in GRAY shading contains a field code, and will NOT automatically update. First, to assure that on your computer variable fields will display as gray in templates, select Tools from the menu and then Options from the drop down list. On the View tab, change the setting for Field Shading to display “Always”, by sel