Harmonization Of US And European Microbial Limits Tests
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As the world continues to flatten, cultural and regional divides gradually disappear. Markets expand across the world, and corporations chase these markets with products and services. If the drug sold to Europe is the same as the drug sold to Japan is the same as the drug sold to the United States, why should the quality control method to analyze it be any different. It is in this spirit of harmonization that is behind the upcoming change in USP Microbial Limits assay. The changes are official and go into effect August 2007.
Microbial Enumeration:
USP <61> has been a staple of US pharmaceutical microbiology laboratories for over a generation. There have not been any substantial changes in this General Test since 1970. What’s immediately evident is that USP <61> Microbial Limits has been divided into two chapters: USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Organisms.
Anthony Grilli is a General Manager for SGS Life Science Services. SGS is the world’s leading testing, inspection, and verification company. With 16 laboratories in North America, Europe, and Asia, the Life Science division offers chemical and biological quality control analysis to the pharmaceutical, biotechnology, and medical device industries.
Tony holds a graduate degree in Microbiology from Rutgers University and the University of Dentistry and Medicine of New Jersey. He has 13 years of contract laboratory management experience and 20 years of industrial laboratory experience. He is a member of ASQ, ASM, ASTM, PDA, CTFA and currently serving as president of the New Jersey chapter of Society for Industrial Microbiology. He has published over 20 articles and is a frequent speaker at scientific conferences.
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•Article: Harmonization Of US And European Microbial Limits Tests