This guidance is intended to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs). The recommendations herein apply to solid non sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions). NSDs can be prescription or nonprescription drugs, including those marketed under approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), and nonprescription drugs without approved new drug applications which are governed by the provisions of section 505G of the FD&C Act (often referred to as over-the-counter (OTC) monograph drugs). 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 (APIs). This guidance discusses product development considerations, risk assessments, and certain CGMPs that are particularly relevant to microbiological control in a manufacturing operation for a NSD. It also provides recommendations to help manufacturers assess the risk of contamination of their NSDs with objectionable microorganisms in order to establish appropriate specifications and manufacturing controls that prevent such contaminations and assure the safety, quality, identity, purity, and efficacy of the NSD.
FDA Link for Guidance: https://www.regulations.gov/document/FDA-2021-D-0432-0002
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