Cryologics, Inc. Newsletter


January 2014


We wish you a very happy New Year! Welcome to the January 2014 issue of our 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. 


Guide to Inspections of Microbiological   Pharmaceutical Laboratories  
20th Anniversary 

FDALast year we marked the 20th anniversary of this important inspection guide. Published by the FDA in July 1993, sections of the guide include: Microbiological Testing of Non-Sterile Products; Facilities, Equipment, and Media; Sterility Testing; Methodology and Validation of Test Procedures; Data Storage; Management Review; and, Contract Testing Laboratories.

The Agency's instructions to its inspectors are still highly relevant to the current cGMP environment. Of particular note, with regard to media growth promotion testing, the Agency states: "Good practice includes the periodic challenge of prepared media with low levels of organisms. This includes USP indicator organisms as well as normal flora" (emphasis added). For two decades, the regulatory expectation is that drug product manufacturers include in-house isolates in this compendial test.

In-House Microbial Isolates in Compendial Testing

Regulatory and Industry Trends
We continue to perform literature research in this area. Our Team has compiled an extensive bibliography of regulatory, compendial and industry references. The chart below demonstrates an increasing trend in citations regarding the use of in-house isolates in compendial testing. Regulatory references include Warning Letters, 483 observations and guidances.  Industry references include published articles by well-known industry subject matter experts.
There have been twice as many citations in the past six years than in the prior 15! The trend is clear... The use of in-house isolates in testing is increasingly a regulatory expectation, and industry thought leaders are recognizing its relevance.

Contact us today!

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In This Issue
Guide to Inspections of Microbiological Pharmaceutical Laboratories
In-House Microbial Isolates: Regulatory and Industry Trends
Product Spotlight

Our CryoLC® and CryoHC® products are your cost-effective solution to preparing your in-house microbial isolates for use in compendial testing.


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* Eliminate your risk of regulatory non-compliance.



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