Cryologics, Inc. Newsletter


September 2013



Welcome to the September 2013 issue of our 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".


Webinar: "In-House Microbial Isolates in Compendial Testing - Regulatory Requirements" 
September 26, 2013

FDATwo decades ago, with its issuance of its "Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories", the FDA made clear its expectation that in-house microbial isolates be incorporated into media growth promotion testing.  Since then, enforcement action has reflected this requirement, and has expanded to disinfectant efficacy testing.  Prominent industry leaders have advocated the use of these "wild type" organisms.  This webinar, hosted by Microrite, Inc., will provide a regulatory background and highlight industry leader insights.  Importantly, it will provide guidance for selecting the appropriate isolates to include in compendial testing in order to meet current regulatory requirements.  Click here for registration information.  Click here for a bibliography of references on this topic.

Contamination Control in Healthcare Product Manufacturing

Parenteral Drug Association
PDA Contamination ControlThe PDA recently published this comprehensive reference book.  It addresses such topics as the role of in-house isolates in contamination control, facility design and control, disinfectant qualification, environmental monitoring, sterility test failure investigations, endotoxins, auditing, biofilms, and risk assessment. Authors include many well-known industry subject matter experts, including Scott Sutton, Karen McCullough, Ziva Abraham, Anne Marie Dixon, Jim Polarine and Jeanne Moldenhauer.  We encourage you to acquire this invaluable reference.  Below is an excerpt from the chapter, "The Role of In-house Microbial Isolates in Contamination Control", authored by Cryologics' President Bob Westney:
"Regardless of the reason for not implementing in-house isolates into compendial testing, the firm risks regulatory scrutiny and enforcement. In response to being cited by a regulatory authority for this lack of compliance, the firm may choose to move quickly to implement the necessary systems, requiring reprioritization of laboratory tasks and rapid deployment of resources. Conversely, the firm may choose to defend its decision not to include its in-house isolates in its testing. The regulatory groundswell during the past several years makes such a defense extremely difficult. Such a defense must include sound scientific rationale. In the absence of any supporting scientific literature demonstrating irrelevance of in-house "wild-type" organisms, the firm must perform its own studies. Such studies would include a broad range of isolates, several media types, genetic analyses, evaluation of growth characteristics, etc. This would appear to be a far more daunting task than simply complying with the regulatory expectation, whether or not the firm agrees with it."

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In This Issue
Webinar: In-House Isolates in Compendial Testing
Contamination Control in Healthcare Product Manufacturing
Product Spotlight

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