摘要
Abstract
OBJECTIVE: To provide reference for pharmaceutical manufacturers mastering the causes of contamination and carrying out relevant prevention measures during the process of pharmaceutical production. METHODS: The media and way of contamination spreading, route of entry during the process of pharmaceutical production were analyzed. Relevant prevention measures were also analyzed. RESULTS & CONCLUSIONS: Common contamination includes physical contamination, chemical contamination and microbial contamination. The media of contamination spreading include air, water, surface, material and staff. The ways of contamination spreading are direct contamination, secondary (multiple) contamination and cross contamination. Routes of entry are people flow channel, logistics channel and air-conditioning channel. Contamination prevention should be conducted in respect of environment control of pharmaceutical production, sanitation control of staff, material and air channel, etc. Thus, pharmaceutical manufacturers must follow GMP requirements to carry out production.关键词
药品/生产过程/污染/成因/防范Key words
Drug/ Production process/ Contamination/ Causes/ Prevention分类
管理科学