您按照药品GMP(2010年修订)的要求适当进行工艺验证了吗？
Do you perform a process validation properly according to GMP Guidelines (revised in 2010)?
激光相变强化工艺参数的硬化层特性影响较大，在产品应用之前必须进行工艺验证。
The technological parameters of LTHT can affect the characteristics of hardening case, so verification must be conducted before applying the product.
不需要，不论cGMP法规还是FDA的政策都没有指定进行工艺验证的最少批次。
No. Neither the CGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process.
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。
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.
工艺性能确认也在“介绍”中被引用，作为验证的一部分，但并没有对术语进行解释。
Process performance verification isalso referred to as part of the validation in the introduction without the termbeing clarified, however.
并利用计算机实体造型和模拟技术进行工艺方案的验证和优化。
The validation and optimization of the technological plans were performed by computer body molding and numerical simulation.
因此有必要在接下来的工作中通过中试研究对该组合工艺进行验证。
Therefore, it is necessary to do pilot operation in the next step to validate this technology hybridization.
对金川镍矿龙首矿混合矿石进行了降镁工艺小型试验和验证试验。
Small scale tests and verification tests of magnesia reduction concentrating process for treating rich lean ore mixture from Longshou Mine in Jinchuan were carried out.
通过大量的试验观察与测量，对投球调剖堵水工艺的可行性和有效性进行了试验验证。
The feasibility and effectiveness of the technology for controlling the injected-water profile in oil Wells with floating spheres are experimentally verified in this paper.
计算与工艺验证，均系在苏州工业园区姑苏电炉有限公司制造的网带炉上进行。
The calculation and verification of the process were carried out all in the net band furnace made in Gusu Electic Furnace Co. , Ltd.
进行工艺控制测试，例如：强度验证，介质控制等。
Perform process control testing, I, e. intensity verification, media control, etc.
小型试验提供的浸出工艺参数，以连续浸出台架试验进行了验证。
The process parameters provided by the batch test have been proved by the continuous bench-scale leaching test.
虚拟装配是虚拟制造的关键技术之一，可在产品设计阶段进行预装配，验证装配工艺的正确性。
Virtual assembly is the key technology of virtual manufacture, virtual products can be pre-assembled at design stage of products, and the correctness of assembly process plans can be verified.
分析了装货口盖成形工艺性，并进行了理论计算和模拟验证，由此制定了该工件的成形工艺、模具设计方案。
The porthole cover forming technology has been analysed and theoretical calculation and simulation verification have been done hence scheme of forming technology and die design done.
在经过工业试验和工业验证试验后，对两座炼铅厂采用该工艺进行了设计，且现已建成投产。
After the industrial and validation tests, the process has been adopted in two smelting plants and now in full operation.
方法采用纯物理的工艺流程过程和紫外线分光光度法从生姜中提取黄酮类物质，对所提取的黄酮类物质进行验证。
MethodsUse purely physical process flow and spectrophotometry to introduce the method of which extracted the flavanone from the gingers, and check the flavanone which extracted from the Lotus rhizome.
试生产阶段：进行小批量试生产，进一步验证产品的工艺性，以及样机试制后设计修正的有效性。
Trial production Stage: Trial production of small lot size shall be carried out to further verify product processibility and effectiveness of design amendment after prototype production.
在所研究理论模型及工艺流程分析的基础上，开发了动力压井工艺参数设计软件，并进行了实例验证。
Based on the research and analysis of the theoretical model and construction process, it developed dynamic kill software, and the example is verified.
采用模拟时的焊接工艺参数进行钨极氩弧焊平板对接焊，测定焊接热循环曲线和焊缝截面尺寸，对模拟结果加以验证。
The welding thermal cycle and section dimensions of the welding seam were measured in the condition of the simulated welding process parameters for checking simulation results.
最后针对S波段接收机前端设计了偏置电路，并按LTCC工艺要求对该接收机前端进行了布局布线和最后的仿真验证。
Finally, bias circuits are designed for the S-band radar receiver LTCC module, the layout and simulated validation are carried out with the LTCC technics requirement.
最后，本文进行了实验研究，验证了链条滚子精密成形工艺方案的可行性和数值模拟的可靠性。
Finally, in thesis, practical research has also been done, which demonstrate the feasibility in plan of the precise forming technology of chain roller and the reliability of numerical simulation.
也许需要进行保留样品的额外测试，以得到必要数量或种类的数据来回对工艺进行回顾性的验证。
Additional testing of retained samples may be needed to obtain the necessary amount or type of data to retrospectively validate the process.
通过对零件的加工工艺进行分析，将能合并的工步源程序串在一起并在实际加工中得到验证从而实现自动换刀加工。
According to analysing the machining technology of part, combine the original procedures which can be incorporated and test them in actual processing thus achieving automatic changing tool machining.
在设施、设备和工艺等，对产品质量会产生重大影响的改变需要进行验证。
Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated.
通过实验对甘薯（芋头）冰淇淋的加工工艺和配方进行了研究，验证了主要工艺参数。
The technology and prescription of taro ice cream have been studied in this paper through experiment and the major technology parameters testified as well.
最后对模拟结果进行了试验验证，并建立了可供实际推弯工艺参考的最佳内压力成形曲线图。
Finally, the simulation results are verified, and the optimal internal pressure forming curve is built as the reference for the practical tube bending.
分别得出了在自然冷却和水冷却条件下的最优工艺参数组合，并分别对其进行了试验验证，验证结果良好。
The optimum process parameters were obtained respectively, and experiment verifications were carried out respectively, verification results were very good.
分别得出了在自然冷却和水冷却条件下的最优工艺参数组合，并分别对其进行了试验验证，验证结果良好。
The optimum process parameters were obtained respectively, and experiment verifications were carried out respectively, verification results were very good.
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