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FDA Guidance for Industry: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing


Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852

Document Type:
´Draft Guidance for Industry
This guidance is intended to assist manufacturers in assuring the control of microbiological2 quality of their non-sterile drugs (NSDs).The recommendations herein apply to solid non18 sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topicallyapplied creams, lotions and swabs, and oral solutions and suspensions).

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