Objectionable microorganisms in pharmaceutical production: Validation of a decision tree
European Journal of Pharmaceutical Sciences(2021)
摘要
•The use of hygienic perspective improves the evaluation of objectionable microorganisms.•The decision tree alone helps the correct decisions for human health protection.•The suggested approach allows an evaluation based on updated and easily checking information.
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关键词
Objectionable microorganism,Decision tree,Non-sterile drugs,Microbial contamination,Drug product quality,Quantitative microbial risk assessment
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