« ROUNDTABLE


Roundtable: 15 Years in Pharmaceutical Microbiology


Donald Singer Global Lead Quality Manager, Microbiology GlaxoSmithKline


Peter Noverini Field Applications Scientist Azbil BioVigilant, Inc.


Mark W. Kaiser Director, Microbiology Eurofins Lancaster Laboratories


Luis Jimenez, Ph.D. Biology and Horticulture Department Bergen Community College


Tim Russell Field Market Developer TSI Inc.


Priya Balachandran, Ph.D. Product Manager Life Technologies


Renaud Jonquieres, Ph.D. Vice President Pharmaceuticals and Cosmetics Franchise bioMérieux


How has the pharmaceutical microbiology arena progressed over the last 15 years? Note some major hurdles and milestones.


alternative methodologies (rapid micro). Suppliers of new technology have begun to ask customers how to apply their technology and have revised their instrumentation packages to fit many different environments.


DS: In Microbiology, some milestones I can note:


• Regulatory scrutiny of sterile products manufacturing has continued to increase and has led to guidance requirements for risk rationale; for example, the rewrite of 21CFR612 for sterility testing, the FDA Guideline for Container Closure Integrity in lieu of Sterility Testing, the MHRA ‘GMP’ Annex 1 pre-filtration bioburden action ‘limit’, and the USP <1116> contamination recovery rate recommendation


• Alignment of regulatory guidance with ICH Quality standards Q7, Q8 and Q9 which impact microbiological risk


• Increased published microbiological control


• Forums and media for communicating microbiological issues and solutions have increased


Some hurdles I have seen are:


• Difficulty in the implementation of new alternative methodologies and concern regarding ‘equivalency’ to pharmaceutical standard methods


• Economics leading to Microbiology labs to lean staffing, less capabilities, less time to innovate, and concern for improvement of supervision of analytical teams that lack experience or sufficient knowledge in the field


• Increase in instrument-based technology jumped ahead of adequate education for users to make good scientific decisions


• Continuation in pockets of the industry where management lacking scientific knowledge oversee microbiology operations


other areas such as manufacturing technology or statistical- and quality- driven design. The creation of microscale, disposable-based manufacturing lines for clinical drug trials and widespread Six-Sigma belt training are examples of peripheral evolutions while strides in microbiology have been


PN: www.americanpharmaceuticalreview.com | | 71


Pharmaceutical microbiology has seen valuable incremental advancements, but has not matched the evolutionary pace of


articles and books about pharmaceutical


Fifteen years is actually a short time span for changes in microbiology. Yet, we’ve seen an increase in considerations for


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