EU GMP ANNEX 15
合集下载
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
d Validation
Principle 1. This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.
9.对于新设施、系统或设备（仪器）的验证，第一部分便是设计确认。 （对象） 10.设计是否与GMP要求符合要经过证明并以书面形式呈现。（要求）
Installation qualification (IQ)
11. Installation qualification (IQ) should be performed on new or modified facilities, systems and equipment. 12. IQ should include, but not be limited to the following: (a) installation of equipment, piping, services and instrumentation checked to current engineering drawings and specifications; (b) collection and collation of supplier operating and working instructions and maintenance requirements; (c) calibration requirements; (d) verification of materials of construction
EU GMP ANNEX15
Qualification and validation
Table of Contents
1.Qualification and Validation 2. Planning for Validation 3. Documentation 4. Qualification 5. Processs Validation 6. Cleaning Validation 7. Change Control 8. Revalidation 9. Glossary
验证计划 2.VMP明确需验证项目并形成文件形式。（明确需做项目，形成文件） 3.VMP应是简短、扼要和清晰的综述性文件（要求） 4.VMP应该至少包括：a.验证方针 b.验证组织结构 c.需要验证的设施、 系统、设备（仪器） 和工艺的汇总 d.文件模板：制定方案和报告的模板 e.计划和时间表f.变更控制 g.参考文件（内容） 5.如果项目庞大，则需要制定一个单独的VMP（例外）
Design qualification（DQ)
Design qualification 9. The first element of the validation of new facilities, systems or equipment could be design qualification (DQ). 10. The compliance of the design with GMP should be demonstrated and documented.
6. 制定书面的方案：①指导验证或确认的实施②写明关键步骤和可接受 标准③经过审核和批准（方案要求） 7.制定报告： ①与相应的方案相互参考②结果的总结、偏差的评价、纠 正缺陷的必要的建议改变③如过方案中计划有任何改变都应书面记录并 给出合理解释。（报告要求） 8.完成满意的确认之后，要以书面批准形式对验证和确认进行正式的放 行。（放行）
Operational qualification 13. Operational qualification (OQ) should follow Installation qualification. 14. OQ should include, but not be limited to the following: (a) tests that have been developed from knowledge of processes, systems and equipment; (b) tests to include a condition or a set of conditions encompassing upper and lower operating limits, sometimes referred to as “worst case” conditions. 15. The completion of a successful Operational qualification should allow the finalisation of calibration, operating and cleaning procedures, operator training and preventative maintenance requirements. It should permit a formal "release" of the facilities, systems and equipment.
13.运行确认在安装确认之后进行 14.运行确认应该包括，但不限于以下方面（内容） a. .根据对工艺、系统和设备的相关认知而制定的测试 b.检查包括上下限 度的条件，有时被称作“最差”条件 15.一份完整成功的运行确认应该包括最终确定的校正、操作和清洁程序， 操作者培训和预防维护要求说明，此步骤的完成相当于允许设施、系统 和设备的正式放行。
Qualification
Design
qualification（DQ) Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ) Qualification of established (in-use facilities, systems and equipment）
Documentation
DOCUMENTATION
6. A written protocol should be established that specifies how qualification and validation will be conducted. The protocol should be reviewed and approved. The protocol should specify critical steps and acceptance criteria. 7. A report that cross-references the qualification and/or validation protocol should be prepared, summarising the results obtained, commenting on any deviations observed, and drawing the necessary conclusions, including recommending changes necessary to correct deficiencies. Any changes to the plan as defined in the protocol should be documented with appropriate justification. 8. After completion of a satisfactory qualification, a formal release for the next step in qualification and validation should be made as a written authorisation.
11.安装确认用于新的或者是变更后的设施、系统和设备（对象）。 12.安装确认应该包括，但是不限于以下方面(内容）。 a.按当前图纸和标准检查设备安装、管道、设施和仪器。 b.收集和整理供应商的操作说明书和维护需求资料。 c.校验要求 d.材质的确认
Operational qualification (OQ)
Planning for Validation
PLANNING FOR VALIDATION
2. All validation activities should be planned. The key elements of a validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent documents. 3. The VMP should be a summary document which is brief, concise and clear. 4. The VMP should contain data on at least the following: (a) validation policy; (b) organisational structure of validation activities; (c) summary of facilities, systems, equipment and processes to be validated; (d) documentation format: the format to be used for protocols and reports; (e) planning and scheduling; (f) change control; (g) reference to existing documents. 5. In case of large projects, it may be necessary to create separate validationmaster plans.
原理 ①适用于医药产品生产者（适用对象） ② GMP要求厂商确定生产的关键步骤得到控制的证明是必须验证的 （为什么）（10版GMP138条） ③可能影响到产品质量的变更应该经过验证（什么情况下）（10版GMP142条） ④风险评估用来确定验证的范围和程度（怎样确定程度）（ 10版 GMP138条）
Principle 1. This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.
9.对于新设施、系统或设备（仪器）的验证，第一部分便是设计确认。 （对象） 10.设计是否与GMP要求符合要经过证明并以书面形式呈现。（要求）
Installation qualification (IQ)
11. Installation qualification (IQ) should be performed on new or modified facilities, systems and equipment. 12. IQ should include, but not be limited to the following: (a) installation of equipment, piping, services and instrumentation checked to current engineering drawings and specifications; (b) collection and collation of supplier operating and working instructions and maintenance requirements; (c) calibration requirements; (d) verification of materials of construction
EU GMP ANNEX15
Qualification and validation
Table of Contents
1.Qualification and Validation 2. Planning for Validation 3. Documentation 4. Qualification 5. Processs Validation 6. Cleaning Validation 7. Change Control 8. Revalidation 9. Glossary
验证计划 2.VMP明确需验证项目并形成文件形式。（明确需做项目，形成文件） 3.VMP应是简短、扼要和清晰的综述性文件（要求） 4.VMP应该至少包括：a.验证方针 b.验证组织结构 c.需要验证的设施、 系统、设备（仪器） 和工艺的汇总 d.文件模板：制定方案和报告的模板 e.计划和时间表f.变更控制 g.参考文件（内容） 5.如果项目庞大，则需要制定一个单独的VMP（例外）
Design qualification（DQ)
Design qualification 9. The first element of the validation of new facilities, systems or equipment could be design qualification (DQ). 10. The compliance of the design with GMP should be demonstrated and documented.
6. 制定书面的方案：①指导验证或确认的实施②写明关键步骤和可接受 标准③经过审核和批准（方案要求） 7.制定报告： ①与相应的方案相互参考②结果的总结、偏差的评价、纠 正缺陷的必要的建议改变③如过方案中计划有任何改变都应书面记录并 给出合理解释。（报告要求） 8.完成满意的确认之后，要以书面批准形式对验证和确认进行正式的放 行。（放行）
Operational qualification 13. Operational qualification (OQ) should follow Installation qualification. 14. OQ should include, but not be limited to the following: (a) tests that have been developed from knowledge of processes, systems and equipment; (b) tests to include a condition or a set of conditions encompassing upper and lower operating limits, sometimes referred to as “worst case” conditions. 15. The completion of a successful Operational qualification should allow the finalisation of calibration, operating and cleaning procedures, operator training and preventative maintenance requirements. It should permit a formal "release" of the facilities, systems and equipment.
13.运行确认在安装确认之后进行 14.运行确认应该包括，但不限于以下方面（内容） a. .根据对工艺、系统和设备的相关认知而制定的测试 b.检查包括上下限 度的条件，有时被称作“最差”条件 15.一份完整成功的运行确认应该包括最终确定的校正、操作和清洁程序， 操作者培训和预防维护要求说明，此步骤的完成相当于允许设施、系统 和设备的正式放行。
Qualification
Design
qualification（DQ) Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ) Qualification of established (in-use facilities, systems and equipment）
Documentation
DOCUMENTATION
6. A written protocol should be established that specifies how qualification and validation will be conducted. The protocol should be reviewed and approved. The protocol should specify critical steps and acceptance criteria. 7. A report that cross-references the qualification and/or validation protocol should be prepared, summarising the results obtained, commenting on any deviations observed, and drawing the necessary conclusions, including recommending changes necessary to correct deficiencies. Any changes to the plan as defined in the protocol should be documented with appropriate justification. 8. After completion of a satisfactory qualification, a formal release for the next step in qualification and validation should be made as a written authorisation.
11.安装确认用于新的或者是变更后的设施、系统和设备（对象）。 12.安装确认应该包括，但是不限于以下方面(内容）。 a.按当前图纸和标准检查设备安装、管道、设施和仪器。 b.收集和整理供应商的操作说明书和维护需求资料。 c.校验要求 d.材质的确认
Operational qualification (OQ)
Planning for Validation
PLANNING FOR VALIDATION
2. All validation activities should be planned. The key elements of a validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent documents. 3. The VMP should be a summary document which is brief, concise and clear. 4. The VMP should contain data on at least the following: (a) validation policy; (b) organisational structure of validation activities; (c) summary of facilities, systems, equipment and processes to be validated; (d) documentation format: the format to be used for protocols and reports; (e) planning and scheduling; (f) change control; (g) reference to existing documents. 5. In case of large projects, it may be necessary to create separate validationmaster plans.
原理 ①适用于医药产品生产者（适用对象） ② GMP要求厂商确定生产的关键步骤得到控制的证明是必须验证的 （为什么）（10版GMP138条） ③可能影响到产品质量的变更应该经过验证（什么情况下）（10版GMP142条） ④风险评估用来确定验证的范围和程度（怎样确定程度）（ 10版 GMP138条）