What are “Objectionable Organisms?”

Webinar to be presented Thursday, June 28 at 2 pm EST

 

Abstract

While most companies use a version of the harmonized microbial limits tests to determine finished product quality for non-sterile manufactured products, the cGMP requirements are for absence of “objectionable” organisms. This webinar will discuss the rationale behind this requirement, and provide some guidance on how to determine if an organism is, in fact, “objectionable.”

Register Here!

Scott Sutton Ph. D.

Dr. Scott Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Microbiology Network, Inc. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals. Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups. This service also supports three Email lists, the first devoted to pharmaceutical microbiology, the second devoted to pharmaceutical stability and the third to cleanrooms and controlled environments.

Key Topics

  • USP vs 21 CFR 211
  • Chapter <1111> and the rationale for "other organisms"
  • How to streamline the research/justification