联合疫苗生产中应考虑的问题生产过程中应考虑的主要问题是生产的一致性,即生产的稳定性,应证明在已确定的生产条件下生产出的产品是稳定和一致的。连的英语翻译

联合疫苗生产中应考虑的问题生产过程中应考虑的主要问题是生产的一致性,即

联合疫苗生产中应考虑的问题生产过程中应考虑的主要问题是生产的一致性,即生产的稳定性,应证明在已确定的生产条件下生产出的产品是稳定和一致的。连续批的数量和规模用于稳定性研究的成品最好是用连续三批原液配制的,应在规模化的生产设施中进行,至少有一批是在大规模生产状态下生产的,以表明该生产工艺在其生产规模改变时是否会对产品的安全、纯度和效力产生影响,尤其对于吸附类产品和不易再悬浮的产品,其成品的质量有可能受到吸附效率或者联合步骤的影响。
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结果 (英语) 1: [复制]
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Issues to be considered in the production of combined vaccines <br>The main issue that should be considered in the production process is the consistency of production, that is, the stability of production. It should be proved that the products produced under the established production conditions are stable and consistent. <br><br>The number and scale of <br><br>continuous batches The finished product used for stability studies is best prepared with three consecutive batches of stock solution. It should be carried out in a large-scale production facility. At least one batch is produced in a large-scale production state to show that Whether the production process will affect the safety, purity and effectiveness of the product when its production scale is changed, especially for adsorption products and products that are not easily resuspended, the quality of the finished product may be affected by adsorption efficiency or combined steps.
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结果 (英语) 2:[复制]
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Issues to be considered in joint vaccine production<br>The main problem to be considered in the production process is the consistency of production, i.e. the stability of production, and the stability and consistency of the products produced under established production conditions should be proved.<br><br>The number and size of consecutive batches<br><br>The finished product used for stability research is preferably made with three batches of raw liquid in a row and should be carried out in a large-scale production facility, at least one of which is produced in a large-scale production state, to indicate whether the production process will have an impact on the safety, purity and effectiveness of the product when its production scale changes, especially for adsorption products and products that are not easily suspended, the quality of the finished product may be affected by adsorption efficiency or joint steps.
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结果 (英语) 3:[复制]
复制成功!
Problems to be considered in production of combined vaccine<br>The main problem that should be considered in the production process is the consistency of production, that is, the stability of production. It should be proved that the products produced under the determined production conditions are stable and consistent.<br>Number and size of consecutive batches<br>The finished products for stability study should be prepared with three consecutive batches of stock solution, which should be carried out in large-scale production facilities, and at least one batch should be produced under large-scale production, so as to show whether the production process will affect the safety, purity and effectiveness of the products when the production scale changes, especially for the adsorption products and products that are not easy to resuspend The adsorption efficiency or combined steps may affect the quality of the adsorbent.<br>
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