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New FDA draft guidance on microbiological quality of NSDs

October 6, 2021


The US Food and Drug Administration (FDA) has released new draft guidance surrounding on ‘Microbiological Quality Considerations in Non-Sterile Drug Manufacturing’. The draft will be available for public comment for up to 90 days after 30 September 2021.

The guidance aims to assist manufacturers in assuring the microbiological quality of their non-sterile drugs (NSDs), with recommendations applying to solid, semi-solid and liquid NSD dosage forms. FDA stated that, if followed, the recommendations will also assist manufacturers in complying with the current good manufacturing practice (cGMP) requirements for finished pharmaceuticals and active pharmaceutical ingredients (APIs).

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