This presentation provides an overview of the current regulatory expectations for the use of in-house microbial isolates in compendial testing. It reviews regulatory, compendial and industry references on the topic. Importantly, it also provides a strategy for selection of these isolates.
Click here to view the presentation.
In this issue, we spotlight the announcement of our new website. We also present Dr. Jeanne Moldenhauer’s article in last month’s issue of American Pharmaceutical Review™, in which she addresses the question of environmental monitoring media and incubation conditions.
Click here for the web version of our May 2014 e-Newsletter.
In this issue, we spotlight the 20th anniversary of FDA’s “Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories”. We also discuss the increasing trend in regulatory and industry citations of in-house isolates in compendial testing.
Click here for the web version of our January 2014 e-Newsletter.
In this issue, we spotlight an upcoming Microrite-hosted webinar on regulatory requirements for inclusion of in-house isolates in compendial testing. We also present an excerpt from the PDA’s recently published book, “Contamination Control in Healthcare Product Manufacturing”.
Click here for the web version of our September 2013 e-Newsletter.
This issue includes several informative articles. The Parenteral Drug Association (PDA) has announced the upcoming publication of an invaluable book on contamination control in healthcare product manufacturing. Cryologics’ President Bob Westney presented at the Controlled Environment Testing Association (CETA) 21st Annual Meeting, and his presentation is available for download. The latest issue of the PMF Newsletter includes articles by Dr. Tim Sandle and by Sung-Oui Suh et al. from the American Type Culture Collection (ATCC).
Click here for the web version of our April 2013 e-Newsletter.