制药工程验证主计划(英文版).pdfVIP

Qualification Master Plan Qualification Master Plan Proj ect Name Proj ect Name Project No. Project No. Plant / Building Plant / Building Unit Unit Equipment Equipment Document Code Document Code Revision Revision Signature Signature Name Reason Function / Department Date Signature Name Reason Function / Department Date Signature Qualification Master Plan Pages 1 of 17 Qualification Master Plan Pages 1 of 17 Table of Contents Table of Contents Table of Contents 2 Table of Contents 2 OVERVIEW / INTRODUCTION 4 OVERVIEW / INTRODUCTION 4 1. Description of roj ect 5 1. Description of roj ect 5 1.1 roj ect Description 5 1.1 roj ect Description 5 1.2 Functional Description 5 1.2 Functional Description 5 1.3 urpose of Qualification Master rotocol (QM ) 5 1.3 urpose of Qualification Master rotocol (QM ) 5 1.4 Main emphasis on quality critical issues 6 1.4 Main emphasis on quality critical issues 6 2. Qualification Approach 6 2. Qualification Appr