Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals
We all know microorganisms are present in environment everywhere, in almost all type of conditions. Also this is known all microorganisms are not harmful only 2% of population is harmful and cause infections. 98% population of microorganisms are useful in running biodiversity on the earth. Those are harmful comes under category of pathogens.
Likewise aseptic or sterile activity regulatory bodies are concerned about contamination of microorganism in formulation other than parenterals.
Crystal M. Booth has provided a good information in following article for non sterile microbiological contamination in formulation.
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