中英对照-APIC原料药厂清洁验证指南：7.0分组法(括号法).docxVIP

APIC 201405原料药厂清洁验证指南：7.0分组法（括号法）和 最差情况分级（中英文） 2014-07-15 julia 翻译蒲公英 7.0 Bracket ing and Worst Case Rat ing 分组法（括号法）和最差情况分级 In troduction 介绍 The cleaning processes of multiple product use equipment in API facilities are subject to requireme nts for clea ning validati on. The validati on effort could be huge. In order to minimize the amount of validation required, a worst case approach for the validati on can be used. 原料药工厂中的多产品设备清洁要求进行清洁验证。清洁工作量会比较大。为了 减少验证的工作量，可以采用最差情形方法进行验证。 By means of a bracketi ng procedure the substa nces are grouped. 采用分组法时，物质按类进行分组。 A worst case rating procedure is used to select the worst case in each group. 然后在每组中采用最差情形分级法选择各组中最差的情况。 Validation of the worst case situation takes place. However, it is of utmost importa nee that a docume nted scie ntific rati onal for the chose n worst cases exists. 对最差情形进行验证。至关重要的是，选择最差情形的科学合理性要进行记录。 This chapter gives an overview of the suggested work to be carried out, the accepta nee criteria and the methodology for evaluati on of the data. It should be emphasized that this is only an example to give guida nee. The equipme nt, the substa nces produced and the procedures in place may vary; and this results in other solutions than those given in this example. 本章介绍了所需要进行的工作、可接受标准和数据评估方法。需要强调的是，这 只是一个指导性的例子，而实际情况下，设备、生产的物质和清洁程序可能有所 不同，则可能需要采用与例中不同的解决方案。 The worst case rati ng priority will the n support a con clusi on that the clea ning procedures are effective for all drug substa nces and other chemicals withi n the bracket, in clud ing those not in dividually tested. 最差情形分级优先性是用来支持清洁方法对组内所有原料药和化学物均有效的 结论的，包括那些并没有进行单独检测的物质。 Bracketi ng Procedure 分组法 The objective of a bracket ing project, is for the compa nyto dem on strate that it has a scie ntific rati on ale for its worst case rat ing of the substa nces in the clea ning validati on program. The first thi ng to do is to make groups and sub groups - which we will term “ bracketing ” , from which worst cases will later be selected based on the results from