中国GMP附录-确认和验证-中英.docxVIP

附件1 Annex 1 确认与验证 Qualification and Validation （征求意见稿） (Draft for Comments) 第一章范围 Chapter One Scope 第一条本附录适用于《药品生产质量管理规范》中涉及的所有确认与验证活动。Article 1 This appendix applies to all qualification and validation activities involved in Good Manufacturing Practice. 第二章原则 Chapter Two Principles 第二条企业应当确定需要进行的确认或验证工作，以证明有关操作的关键要素能够得到有效控制。确认和验证的范围和程度应根据风险评估的结果确认。确认与验证应当贯穿于产品生命周期的全过程。 Article 2 A manufacturer should determine the required qualification or validation activities to prove that the critical aspects of relevant operations can be effectively controlled. The scope and extent of qualification and validation should be determined based on risk assessment results. Qualification and validation activities should be throughout the entire life cycle of a product. 第三章验证计划 Chapter Three Validation Plan 第三条所有的确认与验证活动都应当事先计划。确认与验证的关键要素都应在验证总计划或同类文件中详细说明。 Article 3 All Qualification and validation activities should be planned in advance. The critical aspects of qualification and validation should be specified in a validation master plan (VMP) or an equivalent document. 第四条验证总计划应当包含以下信息： （一）确认与验证的方针； （二）确认与验证活动的组织机构及职责； （三）待确认或验证项目的概述； （四）文件格式，包括确认或验证方案和报告的格式； （五）计划和日程安排； （六）在确认与验证中偏差处理和变更控制的管理； （七）保持持续验证状态的策略，包括必要的再确认和再验证； （八）所引用的文件、文献。 Article 4 The VMP should include the following information: 1) Qualification and validation policy; 2) The organization structure and responsibilities in qualification and validation activities; 3) An overview of the qualification and validation items; 4) Document format, including the format of the qualification or validation protocols and reports; 5) Planning and scheduling; 6) Deviation handling and change control management in the qualification and validation activities; 7) Strategy to maintain the validated status, including requalification and revalidation, where applicable; 8) The referenced files and documents. 第五条对于大型和复杂的项目，可制订单独的项目验证总计划。 Article 5 For a large and complex project, a separate project VMP could be established. 第四章文件 Chapter Fou