What is an "Objectionable Organism"?
نویسنده
چکیده
So, 21 CFR 211.113 limits the discussion to “products not required to be sterile” and 21 CFR211.84 states that the concern is “microbiological contamination that is objectionable in view of its intended use” leaving 21 CFR 211.165 to require lab testing relevant to “drug product required to be free of objectionable microorganisms”. This clearly defined concept of an “objectionable” organism then is one that is:
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