Free Live Webinar

"New Draft FDA Guidance on Microbiological Quality Control in Non-Sterile Drugs
Redefining Microbiological Control for Non-Sterile Products"

December 8, 2021 | 11:30 AM Eastern Time


The presence of the microorganism in Non-Sterile Drugs (NSDs) still pose a risk to pharmaceutical manufacturing and patient safety. The number of incidents with NSDs microbial contamination resulting in serious adverse events, deaths and recalls continues to be of concern. FDA has issued multiple warnings during recent years and more recently published a draft guidance.

In this webinar, we will discuss 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 NSDs. The presence of microorganisms in sterile drug products is of paramount concern to patient safety. It is less obvious why concern for the presence of microorganisms in NSDs exists.

The purpose of this new guidance is to assist manufacturers in assuring the microbiological quality of their non-sterile drugs (NSDs).

The New Draft FDA Guidance is focused on four (4) key sections:

  • Statutory and regulatory framework

  • Microbiological concerns for NSDs

  • Risk-based impact assessment with both product specific and manufacturing elements explored

  • Microbiological concerns for specific dosage forms and special cases, including solid and non-solid forms

  • Updating approved drug product specifications