浅析药品生产设备的清洁验证

2011年国家颁布新修订的《药品生产质量管理规范》,对药品生产中如何防止污染与交叉污染提出了更加明确的要求。药品生产后必须对相应设施采取一定的程序进行清洗,防止药物成分残留到下一批产品中,形成交叉污染,影响产品质量,甚至造成质量事故。而清洁验证是证实清洗程序合理性的必要技术手段。目前,部分药品生产企业在清洁验证实施中存在着验证目标产品选择不当、残留限度确定不准确、验证状态难以保持等多方面的问题。本文从清洁验证的范围、常规要求、残留物接受限度的确定、产品与设备评估等方面对清洁验证进行全面的阐述。

Cleaning validation of drug manufacturing equipment

The revised version of Chinese GMP issued in 2011 put forward the specific requirements regarding how to prevent contamination and cross contamination during the drug manufacturing process. Cleaning complied with the concerned cleaning procedures for the relevant equipment must be implemented after drug production in order to prevent the residual drug ingredients from cross contaminating the next batch of products,affacting the quality of products and even causing the quality incident. The cleaning validation is a indispensable technical means to prove the rationality of the cleaning process. Currently,there are problems in the implementation of cleaning validation in some of the drug manufacturers,such as inappropriate selection of target product,inaccurate determination of limit of residue and difficulty in maintaining the validation status,etc. This thesis describes cleaning validation comprehensively including the scope of cleaning validation,regular requirements,determination of acceptance of limit of residue,and evaluation of product and equipment,etc.