| 1. | Guide for technological management . engineer verification
工艺管理导则.工艺验证 |
| 2. | Validation of such processes should be based on historical data
该工艺验证应该以历史数据为基础。 |
| 3. | 3your proposal should provide details on your plans for in process verification
你方建议书需根据计划提供详细况情，以作生产工艺验证。 |
| 4. | Application of dissolution on process change control and some issues for its methodology development
溶出度在工艺验证中运用及方法学建立时的若干问题 |
| 5. | Batches made for process validation should be the same size as the intended industrial scale batches
工艺验证批次的生产规模应该与已定的工业生产批次相同。 |
| 6. | Review the validation status of analytical methods validation , process validation and cleaning validation for products
产品的分析方法验证、工艺验证、清洁验证的验证状态的审核。 |
| 7. | Process validation should normally be completed prior to the distribution and sale of the medicinal product ( prospective validation )
工艺验证通常应该在医药产品分发销售（预验证）前完成。 |
| 8. | Validation of a process for a product which has been marketed based upon accumulated manufacturing , testing and control batch data
以积累的生产、检验和控制批次数据为基础的、已经上市产品的工艺验证。 |
| 9. | In exceptional circumstances , where this is not possible , it may be necessary to validate processes during routine production ( concurrent validation )
如有例外情况使工艺验证不能如期进行，则必须在日常生产过程中进行验证（同步验证） 。 |
| 10. | A repeat of the process validation to provide an assurance that changes in the process / equipment introduced in accordance with change control procedures do not adversely affect process characteristics and product quality
一个重复性的工艺验证，用来保证符合变更控制程序的工艺/设备方面的变更不会对工艺性质和产品质量产生负面影响。 |
