编号：
时间：2021 年 x 月 x 日
书山有路勤为径，学海无涯苦作舟
页码：第 4 页 共 32 页
1. 厂房设施设计以及公用设施与设备确认 ...................................................................... 14
2. Process Performance Qualification ......................................................................................... 16
2. 工艺性能确认 ...................................................................................................................... 16
3. PPQ Protocol ........................................................................................................................... 17
3. 工艺性能确认方案 ............................................................................................................. 17
4. PPQ Protocol Execution and Report ....................................................................................... 19
4. 工艺性能确认执行与报告 ................................................................................................ 19
D. Stage 3 - Continued Process Verification ......................................................................................... 20
D. 第三阶段 - 持续工艺验证 ........................................................................................................ 20
V. CONCURRENT RELEASE OF PPQ BATCHES ....................................................................................... 22
五. 工艺性能确认批次的同时放行 ......................................................................................................... 22
VI. DOCUMENTATION .................................................................................................................................. 24
六. 文件记录 ................................................................................................................................................ 24
VII. ANALYTICAL METHODOLOGY ............................................................................................................... 24
七. 分析方法 ................................................................................................................................................ 24
GLOSSARY ................................................................................................................................................... 26
术语表 .......................................................................................................................................................... 26
REFERENCES............................................................................................................................................... 28
参考资料...................................................................................................................................................... 28
包含不具约束力的建议
1
Guidance for Industry1
行业指南 1
Process Validation: General Principles and Practices
工艺验证：一般原则与实施
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does
not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can
use an alternative approach if the approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number
listed on the title page of this guidance.
本指南体现了食品药品管理局（FDA）关于这一主题的最新见解。本指南不为任何人或
对任何人才创造或赋予任何权利，不起束缚 FDA 或公众的作用。如果替代方法能够满足适
用法律、法规的要求，您可以使用替代方法。如果您希望讨论一种替代性方法，请与负责执
行本指南的 FDA 工作人员联系。如果您不能确定相应的 FDA 工作人员，请拨打本指南标题
页所列的相应电话号码。
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