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| 摘要: |
| 本文主要对工艺验证的含义、进行工艺验证的前提条件、工艺验证方案和工艺验证报告的具体内容进行了阐述，并以某片剂为例进行了进一步详述。工艺验证是确证生产工艺是否可连续生产出符合质量标准要求的产品的研究过程，进行工艺验证前，应通过详细的工艺研究对工艺有充分的理解。工艺验证方案是用于指导如何具体实施工艺验证的文件，工艺验证报告是如实记录工艺验证结果并对验证结果进行评价的文件。 |
| 关键词: 工艺验证 工艺验证方案 工艺验证报告 |
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| Preliminary Analysis of the Process Validation for Orally Solid Drugs |
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XU Zhenyu
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| Abstract: |
| The objective of process validation, the precondition of process validation, the protocol and report of process validation are introduced in this paper, tablets are taken as an example for detailed illustration. Process validation is the documented evidence that a process is capable of consistently delivering quality product. The manufacturing process should be understood well before process validation. Validation protocol is a document that specifies how validation of a particular process will be conducted. Validation report is a document that summarizes and evaluates the results obtained. |
| Key words: process validation validation protocol validation report |
