中国GMP附录-确认和验证-中英

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 Four Documentation

第六条确认与验证方案应当经过审核和批准。确认与验证方案应当详述关键要素和可接受标准。

Article 6 A qualification or validation protocol should be subject to review and approval. The qualification or validation protocol should define in detail the critical factors and the acceptance criteria.

第七条供应商或第三方提供的确认与验证的方案、数据或报告，企业应当对文件的适用性和符合性进行审核、批准。

Article 7 Where qualification and validation protocols are supplied by a supplier or a third party, the manufacturer should review their suitability and compliance before approval.

第八条确认或验证活动结束后，应当及时汇总分析获得的数据和结果，撰写确认或验证报告。企业应当在报告中对确认与验证过程中出现的偏差进行评估，必要时进行彻底调查，并采取相应的纠正措施和预防措施；对于已批准的确认与验证方案的变更，进行评估并采取相应的控制措施。确认或验证报告应当经过书面审核、批准。

Article 8 A qualification or validation report should be prepared in a timely manner, summarizing and analyzing the data and results obtained after qualification or validation activities are completed. The manufacturer should assess any deviations identified during the qualification and validation activities, and conduct a thorough investigation and take relevant corrective actions and preventive actions, if necessary. Any changes to an approved qualification or validation protocol should be assessed and relevant control measures should be taken. The qualification and validation report should be reviewed and approved in written.

第九条当验证结果不符合预先设定的可接受标准时，应当进行记录并分析原因。企业如对原先设定的可接受标准进行调整，需进行科学评估，得出最终的验证结论。　

Article 9 Any validation results that fail to meet the pre-defined acceptance criteria should be recorded and a cause analysis should be conducted. Any subsequent changes to the pre-defined acceptance criteria should be scientifically justified and a final validation conclusion should be made.

第十条当确认或验证分阶段进行时，只有当上一阶段的确认或验证活动符合预定目标且经书面批准后，方可进行下一阶段的确认或验证活动。上一阶段的确认或验证活动中某项预先设定标准不能满足或偏差处理未完成，经评估对下一阶段的确认或验证活动无重大影响，企业可对上一阶段的确认或验证活动进行有条件的批准。