Concurrent validation may be conducted on a previously validated process to confirm that the process is validated 同步驗(yàn)證可以用于對(duì)先前已經(jīng)驗(yàn)證過(guò)的工藝進(jìn)行確認(rèn)。
In exceptional circumstances , where this is not possible , it may be necessary to validate processes during routine production ( concurrent validation ) 如有例外情況使工藝驗(yàn)證不能如期進(jìn)行,則必須在日常生產(chǎn)過(guò)程中進(jìn)行驗(yàn)證(同步驗(yàn)證) 。
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(guò)驗(yàn)證是基于在經(jīng)過(guò)確認(rèn)的設(shè)備上的常規(guī)生產(chǎn)。
32 the detail given in these two sections again indicates that if material is " reworked " a much deeper assessment should be made of the resulting product and the advice that concurrent validation is a suitable means of dealing with " reworking " only underlines the fact that it would be insufficient solely to check the reworked material against the original specification , due to the possibility of that reworked material may contain new impurities or may have different physical properties such as crystal structure 32這兩部分所給出的細(xì)節(jié)說(shuō)明,如果對(duì)一個(gè)產(chǎn)品進(jìn)行了再加工,需要對(duì)產(chǎn)品結(jié)果進(jìn)行更深入的評(píng)估,關(guān)于“同步驗(yàn)證是處理再加工的恰當(dāng)方法”意味著僅僅根據(jù)最初的技術(shù)標(biāo)準(zhǔn)對(duì)再加工物料產(chǎn)品進(jìn)行檢查是不夠的,因?yàn)樵偌庸ぴ牧现杏锌赡芎行碌碾s質(zhì)或存在不同的物理性狀例如晶狀體等。