清洁验证的法规要求

CLEANING VALIDATION 清洁验证

1 Cleaning validation should be performed in order to confirm the effectiveness of a cleaning procedure. The rationale for selecting limits of carry over of product residues, cleaning agents and microbial contamination should be logically based on the materials involved. The limits should be achievable and verifiable.

清洁验证是为了确保清洁程序的有效性而进行的。对于产品残留物清除、清洁剂和微生物污染的限度选择，理论上应该以相关原料为基础。这些限度应该是可以达到的并且是可以被证实的。

2 Validated analytical methods having sensitivity to detect residues or contaminants should be used. The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminant.

应该使用经确认的、对于检测残留物或污染物具有灵敏度的分析方法。每一种分析方法的检测限度应该足够灵敏来检测出符合可接受标准要求的残留物或污染物。

3 Normally only cleaning procedures for product contact surfaces of the equipment need to be validated. Consideration should be given to non-contact parts. The intervals between use and cleaning as well as cleaning and reuse should be validated. Cleaning intervals and methods should be determined.

一般情况下，仅仅对于和产品接触的设备表面需要进行清洁验证。也要考虑到非接触部分。要对使用清洁间隔以及清洁再使用间隔进行验证。清洁间隔和方法应该是确定的。

4 For cleaning procedures for products and processes which are similar, it is considered acceptable to select a representative range of similar products and processes. A single validation study utilising a “worst case” approach can be carried out which takes account of the critical issues.

对于相似产品和工艺的清洁程序，选择相似产品和工艺具有代表性的范围是可以接受的。当考虑到关键结果时，可以利用“最坏情况”来进行单独的验证研究。

5 Typically three consecutive applications of the cleaning procedure should be performed and shown to be successful in order to prove that the method is validated.

应该使用典型的连续三次清洁程序并保证结果成功，以证明该方法是经过验证的。

6 "Test until clean". is not considered an appropriate alternative to cleaning validation. “一直测试直到干净为止”这种做法不能作为在清洁验证中的适当的选择的考虑。

7 Products which simulate the physicochemical properties of the substances to be removed may exceptionally be used instead of the substances themselves, where such substances are either toxic or hazardous.

当要被清除的物质有毒或者存在危险性时，要使用产品而非该物质本身，产品同该物质具有相似的物理化学特性。