Objectionable microorganisms in pharmaceutical production: Validation of a decision tree

The release of quality, safe, and effective non-sterile drugs needs to exclude the presence objectionable microorganisms, which include microorganisms potentially involved in product degradation, or considered as poor hygiene indicator during manufacturing, causing adverse effect on patient's health. In this paper, a method allowing objective verifiable evaluations has been investigated through development suitable decision tree with template for data collection. used establish were objectionables, using several hypothetical scenarios 24 different biological agents, both harmless opportunistic pathogens, combined 9 products, representing each type administration route drugs. results showed that use aforementioned approach makes evaluation easy highlighted even microbes initially could be objectionable.