Without process validation documentation, you cannot demonstrate that your manufacturing process can consistently produce API that meet predetermined quality attributes.
没有工艺验证资料，你们就无法证明你们的生产工艺可以持续生产出符合既定质量属性的API。
| 单词 | Process validation |
| 释义 |
Process validation
原声例句
FDA警告信英语 Without process validation documentation, you cannot demonstrate that your manufacturing process can consistently produce API that meet predetermined quality attributes. 没有工艺验证资料，你们就无法证明你们的生产工艺可以持续生产出符合既定质量属性的API。
英语百科
Process validationProcess Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification. |
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