MEETING REGULATORY EXPECTATIONS

摘要

Research is revealing more information about microbes found on humans and in the manufacturing environment, changing the way microbiological strategies and tests are devised. Pharmig's annual conference, held in Nottingham, UK, highlighted some areas where pharmaceutical regulators have embraced these new concepts but have not, as yet, mandated or specified procedures in the standards. Tim Sandle, Site Microbiologist, BPL began the proceedings by looking at recent research from the Human Microbiome Project (HMP) and its implications for cleanroom microbiology. Research on the HMP has revealed that there are some 1,000 different species of microbes found on men and women, and it is now recognised that a human adult houses about 10~(12) bacteria on the skin, 10~(10) in the mouth and 10~(14) in the gastro-intestinal tract. There is also a considerable diversity of species and a variation between individuals.