工艺验证方案模板

Verification department (department):验证科室（部门）：Verify completion date:验证完成日期：Validity:有效期：Index 目录1.Purpose目的 (5)2.Scope范围 (5)3.Responsibility职责 (5)3.1 AAA responsibilities AAA的职责 (5)3.2 XXX responsibilities XXX的职责 (5)4.Regulation and Guidance 法规和指南 (7)5.Abbreviations缩略语 (8)6.Protocol Description方案说明 (10)7.Product And Process Description产品和工艺描述 (12)7.1 Product specification (12)7.2 Drug approval No. (12)7.3 Standard Followed: (12)7.4 Raw Materials and Adjuvants原辅料情况 (12)7.5 Process description: (14)7.6 Process Recipe工艺处方： (18)7.7 List of Production Plants生产车间一览 (23)7.8 List of Production Equipment 生产设备一览 (25)7.9 Process Flow Diagram 工艺流程图 (28)7.10 CPP Identification CPP确认 (28)7.11 Validation Plan验证计划 (42)8.Validation prerequisite验证先决条件 (44)8.1 Personal Identification人员确认 (44)8.2 Process Documentation Verification 生产文件确认 (44)8.3 Training Verification 培训确认 (45)8.4 System and Equipment Instruments Calibration Verification 系统和设备仪表校验确认.. 458.5 System and Equipment Instruments Calibration Verification 生产相关验证状态确认 (46)8.6 Test Instruments Calibration Verification 测试仪器和仪表校验确认 (46)8.7 Testing Method Validation Verification检验方法验证的确认 (46)8.8 Raw Material and Excipient Verification原辅料确认 (47)9.Sampling Plan and Evaluation Criteria取样计划及评估标准 (49)10.Sample Coding Method样品编码原则 (62)11.Process Validation Test Execution 工艺验证执行 (64)11.1 Liquid Preparation 液体配制 (64)11.2 Cell Resurrection and Passage细胞复苏及传代 (66)11.3 Harvest liquid test 收获液检测 (72)11.4 Clarification Filtration Efficacy Test 澄清过滤效果检测 (73)11.5 UF Concentration 1 Efficacy Test超滤浓缩1效果检测 (74)11.6 Ammonium sulfate precipitation efficacy test 硫酸铵沉淀效果检测 (75)11.7 Potassium bromide extraction efficacy test 溴化钾提取效果检测 (76)11.8 First density gradient centrifugation efficacy test 一次密度梯度离心效果检测 (77)11.9 Second density gradient centrifugation efficacy test 二次密度梯度离心效果检测 (78)11.10 UF Concentration 2 Efficacy Test 超滤浓缩2效果检测 (79)11.11 Chromatography purification product test 层析纯化产物检测 (80)12.Bulk Determination原液检验 (82)13.Process Validation Summarization工艺验证总结 (83)14.PV Report工艺验证报告 (83)14.1 Process Validation Report 工艺验证报告 (83)14.2 Process Validation Analysis and Evaluation 工艺验证分析与评价 (84)15.Requirements on Execution Records 执行记录要求 (84)16.Deviation Handling 偏差处理 (84)17.Change Handling 变更处理 (85)18.Test Form测试表 (86)表格1 缩略语 (8)表格2原辅料质量标准表 (10)表格3物料消耗表1 (18)表格4物料消耗表2 (19)表格5所用液体配料表 (19)表格6生产车间一览表 (23)表格7主要生产设备一览表 (25)表格8工艺风险分析表 (33)表格9工艺时间表 (42)表格10取样计划表 (49)表格11样品编码原则 (62)表格12配液取样检测信息表 (64)表格13复苏和传代取样表 (66)表格14复苏和传代样品编码 (72)表格15收获液标准 (73)表格16澄清过滤标准 (74)表格17超滤浓缩1标准 (74)表格18硫酸铵沉淀标准 (75)表格19溴化钾提取标准 (76)表格20一次密度梯度离心标准 (77)表格21二次密度梯度离心标准 (78)表格22超滤浓缩2标准 (79)表格23纯化产物标准 (80)表格24原液标准 (82)表格25测试表列表 (86)1. Purpose目的This purpose of this process validation is to provide documented evidence to show that the combination of the personnel, materials, equipment, methods, environmental conditions and the other related utilities XXX Co., LTD (XXX) can ensure the consistent production of products conforming to the enterprise internal standards and the national standards, and the processes are reliable and conforming to the GMP requirements. The process validation and the test results are to be documented based on this validation protocol.本工艺验证用于提供文件化的证据，证明XXX疫苗一室生产XXX原液的人员、材料、设备、方法、环境条件以及其它有关公用设施的组合可以始终如一的生产出符合企业内控标准及国家法定标准的产品，工艺稳定可靠，符合GMP要求，工艺验证的过程和检查的结果将按照该验证方案进行记录。

2. Scope范围This protocol is applicable to the process validation of XXX produced by the equipment located XXX.本方案适用于XXX原液生产的工艺验证。

由于工作细胞库制备的过程并非常规生产过程，因此，不在本次验证中进行考察。

The labeling and packaging processes are not within the scope of this document since these processes have been validated per PQ protocol (labeling) and PQ protocol (packaging), and these processes have minimal impact on finished product quality.贴标签和包装也不在此文件范围内，因为这些工艺已经按照PQ方案（贴标签）和PQ方案(包装)验证过，并且这些工艺对产品质量极少有影响。

3. Responsibility职责3.1 AAA responsibilities AAA的职责✓Compile Protocol方案的编写✓Guide Protocol execution, data collection/ Provide test data for review upon request by customer指导方案的实施，数据的收集/在客户要求时提供测试数据供其审核✓Final report Review/ Analyze and compile data into the summary report最终报告的审核/对数据进行分析并将其编辑入总结报告之中3.2 XXX responsibilities XXX的职责⏹Production department 生产部✓Review and approve protocol审核并批准验证方案✓Assure all the equipment used for validation can be maintained timely 保证验证用所有设备均能按SOP进行及时的维护和保养✓Assure all the raw materials used for validation can be supplied timely and comply with domestic quality criteria of enterprise保证验证用原辅包装材料能按时到货，并符合企业内控标准⏹Research and development department 研发部✓Provide product registration criteria and review whether recipe and process step described in the protocol is complying with registered criteria提供产品的注册工艺，审核方案中生产处方、工艺与注册资料的一致性✓Review and make assurance the compliance of raw material supplier with registered supplier审核原辅料供应商和注册资料的一致性✓Review relevant quality criteria including raw material, intermedia and finished product 审核原辅料标准、中控质量标准和成品的质量标准⏹Vaccine one Plant 疫苗一室✓Coordination and implementation of this validation protocol协调、实施本验证方案✓Training of personnel based on this validation protocol按验证方案对有关人员进行培训✓Collection, sorting and reviewing of validation data and drafting of validation reports (including the deviation report, if there are any deviations)收集、整理和审核验证数据，起草验证报告（如方案执行有偏差，要完成偏差报告）。