Session: Special Topic 3: Current Microbiology Topics

Live Q&A (ST3)

Tuesday, September 28, 2021

08:49 – 09:30 EDT

In 1993, the FDA published the Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories that described the use of “normal flora” (current term, environmental isolates (EI)) in addition to the USP designated Quality Control microorganisms to evaluate growth promotion of microbiological culture media. The original guidance recommendation, over the last few decades, has expanded to the inclusion of EI in a broader range of microbiological methods becoming a standard regulatory inspectional observation. This presentation will discuss use of EIs for compendial methods that have prescribed microorganisms that are representative of the most commonly encountered EIs. The discussion will also focus on when EI use is appropriate for inclusion with method validation and other microbiological applications.

Moderator(s)

Mary E. Farbman, PhD

Associate Vice President, Global Auditing and Compliance Support
Merck & Co., Inc.
Newton, Massachusetts, United States

Panelist(s)

Dennis E. Guilfoyle, MS, PhD

Senior Director, Microbiology Regulatory Compliance
Johnson & Johnson
New Brunswick, New Jersey, United States
Stephen E. Langille

Microbiology Consultant
ValSource
Mount Airy, Maryland, United States

Regulatory Panelist(s)

Robert M. Barbosa

Drug Specialist and Pre-Approval Manager, ORA
U.S. FDA
Indianapolis, Indiana, United States