Batches made for process validation should be the same size as the intended industrial scale batches 工藝驗(yàn)證批次的生產(chǎn)規(guī)模應(yīng)該與已定的工業(yè)生產(chǎn)批次相同。
Review the validation status of analytical methods validation , process validation and cleaning validation for products 產(chǎn)品的分析方法驗(yàn)證、工藝驗(yàn)證、清潔驗(yàn)證的驗(yàn)證狀態(tài)的審核。
Process validation should normally be completed prior to the distribution and sale of the medicinal product ( prospective validation ) 工藝驗(yàn)證通常應(yīng)該在醫(yī)藥產(chǎn)品分發(fā)銷售(預(yù)驗(yàn)證)前完成。
4 concurrent validation includes a process validation with the same requirements as for prospective studies , but performed during routine production on qualified equipment 4同步驗(yàn)證同前驗(yàn)證類似,不過驗(yàn)證是基于在經(jīng)過確認(rèn)的設(shè)備上的常規(guī)生產(chǎn)。
Event handlers for immediate event components execute in the apply request values phase , which happens before the process validation phase of the rest of the components 即時事件組件的事件處理程序是在應(yīng)用請求值階段執(zhí)行的,這發(fā)生在其余組件的類型轉(zhuǎn)換和有效性驗(yàn)證之前。
5 methods used for package process validation , which include the machine process , the effects of the sterilization process , distribution , handling , and shipping events , are beyond the scope of this guide 包裝程序驗(yàn)證方法,包括機(jī)器制造過程,滅菌過程,銷售,處理和運(yùn)輸,都在此指南范圍內(nèi)。
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 一個重復(fù)性的工藝驗(yàn)證,用來保證符合變更控制程序的工藝/設(shè)備方面的變更不會對工藝性質(zhì)和產(chǎn)品質(zhì)量產(chǎn)生負(fù)面影響。
As the mac services provider , honeywell can apply its integrated strategy to each design phase , including front - end engineering development , early operator training and process simulation , advanced control modeling , process validation and advanced process control 作為主自動化承包商服務(wù)供應(yīng)商,霍尼韋爾可以在每個設(shè)計(jì)階段應(yīng)用其整合策略,包括前期工程的開發(fā)、早期操作員的培訓(xùn)和流程模擬、高級控制模型、工藝驗(yàn)證和高級過程控制。