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对生产结束后按清洁规程对系统进行清洁,然后进行清洁灭菌效果的取样检测无菌、内毒素、残留量等各项检测项目均符合标准,表明现行的清洁规程能有效地清洁生产系统及设备,防止交叉污染,保证下批产品规定的疗效、质量和安全性的状态,符合GMP生产要求。在产品生产后,若残留活性成分及其降解产物、辅料等,直接进入下批生产过程,必然对下批产品产生不良影响,根据GMP及《药品生产验证指南(2003)》[1]的要求,必须对其生产系统及设备的清洁方法进行定期的清洁验证,冻干粉针剂具有生产工艺相对复杂、其清洁验证难点在于残留、无菌取样方法与取样点的确定,对配液灌装系统进行取样点分析确定、对取样与检验方法进行验证,得出真实可靠的结果。
After the completion of the production according to the cleaning procedures to clean the system, and then clean the sterilization effect of the sampling and testing of aseptic, endotoxin, residues and other testing items are in line with the standards show that the current cleaning procedures can effectively clean the production system and Equipment, to prevent cross-contamination, to ensure the next batch of products under the conditions of efficacy, quality and safety, in line with GMP production requirements. After the production of the product, if the active ingredient and its degradation products, excipients and the like remain in the production process of the next batch, it will inevitably have an adverse effect on the products in the next batch. According to the requirements of GMP and the Guide for the Validation of Pharmaceutical Production (2003) [1] , Must carry on the periodic cleaning verification to the cleaning method of its production system and the equipment, the freeze-dried powder injection has the relatively complicated production process, the cleaning verification difficulty lies in the residue, the aseptic sampling method and the determination of sampling points, Sampling point analysis to determine the sample and test methods to verify, come to real and reliable results.