FDA Announces Availability of Draft Guidance - Microbiological Quality Considerations in Non-sterile Drug Manufacturing

This guidance discusses product development considerations, risk assessments, and certain current good manufacturing practice (CGMP) require

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Announces Availability of Draft Guidance - Microbiological Quality Considerations in Non-sterile Drug Manufacturing   The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled, "Microbiological Quality Considerations in Non-sterile Drug Manufacturing." This guidance is intended to assist non-sterile drug (NSD) manufacturers in assuring the microbiological quality of their drugs. 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 NSD manufacturing operation. The recommendations in this guidance apply to solid, semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions). Non-sterile drugs can be prescription or nonprescription drugs, including those marketed under approved new drug applications or abbreviated new drug applications, 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 OTC monograph drugs). These recommendations, if followed, will assist manufacturers in complying with CGMP requirements for finished pharmaceuticals and active pharmaceutical ingredients. This guidance discusses incidents of Burkholderia cepacia complex (BCC) and other microorganism contamination in drugs that resulted in adverse events, including serious  infections and deaths. The guidance describes proper prevention of and testing for BCC in aqueous dosage forms of non-sterile drugs. The agency continues to alert drug manufacturers of recent product recalls associated with BCC. FDA reminds drug manufacturers of their responsibilities to prevent microbiological contamination in manufacturing processes and products.  The guidance also describes the agency's current thinking on preventing microbiological contamination of topical antiseptic drugs intended for use by health care professionals in  hospital or other healthcare settings as part of medical procedures to reduce the number of bacteria on the skin in light of the fact that some of these products are not manufactured as sterile.   The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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