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Updated: Nov 17

"Microbiological Quality Considerations in Non-sterile Drug Manufacturing"


Firms must have a microbial control strategy by establishing a program to monitor and control the manufacturing process to prevent objectionable microorganisms from affecting the quality of NSDs.

This Guidance was developed to assist manufacturing firms in assuring the control of

microbiological quality of their non-sterile drugs (NSDs) with applicability to Solid, semi-solid and liquid non-sterile dosage forms.



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