药品包装过程污染来源及防控措施

目的减少药品包装过程污染,提高药品质量。方法分析药品包装过程中污染引入途径,并按《药品生产质量管理规范(GMP)》要求,从企业开展药品包装工作的角度,阐述如何有效防控包装污染。结果企业可从人员污染、包装材料污染和空气污染3个方面防控。结论药品包装过程是药品生产过程中药品质量与质量安全风险最高的环节,防止污染的发生极其重要。

Source and Prevention of Pollution in Drug Packaging Process

Objective To reduce pollution during drug packaging process and improve the drug quality.Methods The way of contamination in the process of drug packaging was analyzed;the effective method to prevent and control packaging pollution was stated according to the requirements of the Good Manufacturing Practice for Drugs(GMP)and from the perspective of the enterprises’drug packaging work.Results The enterprise could prevent and control pollution from three aspects:personnel pollution,packaging material pollution and air pollution.Conclusion The drug packaging process has the highest risk for drug quality and safety in the drug production process,and it is extremely important to prevent the occurrence of pollution during this process.