Drugs

Guidance on Microbiological Quality in Non-Sterile Drugs

FDA has published a draft guidance, Microbiological Quality Considerations in Non-Sterile Drug Manufacturing, to assist manufacturers in ensuring the control of the microbiological quality of their non-sterile drugs. The document’s recommendations apply to solid, semi-solid, and liquid non-sterile dosage forms.

FDA says the non-sterile drugs can be prescription or nonprescription, including those marketed under an ANDA or as an over-the-counter monograph drug.

“These recommendations, if followed, will also assist manufacturers in complying with the current good manufacturing practice (CGMP) requirements for finished pharmaceuticals and active pharmaceutical ingredients,” the guidance says.

The guidance discusses product development considerations, risk assessments, and certain CGMPs that are particularly relevant to microbiological control in a manufacturing operation for a non-sterile drug. It also has recommendations to help manufacturers assess the risk of contamination of their non-sterile drugs with objectionable microorganisms to establish appropriate specifications and manufacturing controls that prevent such contaminations and assure the safety, quality, identity, purity, and efficacy of the non-sterile drug.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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