论文部分内容阅读
目的探讨非无菌制剂制药设备清洁标准操作规程(SOP)的制定,从程序设计上保证设备清洁后的残留物达到可接受标准,最大限度地保证消费者的用药安全。方法从《药品生产质量管理规范》(2010版)的基本要求入手,对污染物、清洁剂、消毒剂、清洁方法、产品分组进行了分类探讨,结合实例做简要介绍。结果与结论非无菌制剂设备清洁SOP应根据物料的特点、设备的特点分别制定,使其具有较强的可操作性、重现性、科学性、合理性。清洁人员必须严格按照批准的清洁SOP操作,防止人为因素导致的差错事故,从而保证清洁效果,保证药品质量。
OBJECTIVE To study the development of standard operating procedure (SOP) for non-sterile pharmaceutical preparation equipment, to ensure that the residue after equipment cleaning achieves acceptable standards in terms of program design, and to ensure the safety of consumer medication to the maximum extent. Methods Starting with the basic requirements of “Good Manufacturing Practices for Pharmaceutical Production” (2010 edition), the paper discussed the classification of pollutants, detergents, disinfectants, cleaning methods and product groupings, and made a brief introduction with examples. Results and Conclusion The non-sterile preparation equipment cleaning SOP should be formulated according to the characteristics of the material and the characteristics of the equipment, respectively, so that it has strong operability, reproducibility, scientificity and rationality. Cleaning personnel must strictly follow the approved cleaning SOP operation to prevent human error caused by accident, so as to ensure the cleaning effect and ensure the quality of medicines.