Microbiological Quality Considerations in Non-Sterile Drug Manufacturing; Draft Guidance for Industry; Availability, 86 FR 54210

Summary

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Microbiological Quality Considerations in Non-Sterile Drug Manufacturing.” The purpose of this guidance is to assist manufacturers in assuring the microbiological quality of their non-sterile drugs (NSDs). This guidance discusses product development considerations, risk assessments, and certain current good manufacturing practice (CGMP) requirements that are particularly relevant to microbiological control in a manufacturing operation for an NSD.