关键词：医药；药品；微生物监测；制药工业
摘 要：Microbiological testing plays an ever increasing role in delivering high quality drug products to patients, whether it's practiced in the pharmaceutical laboratory and in the manufacturing environment. In response to the drive for continuous improvement and further economies, a variety of new methodologies have emerged in recent years which automate existing methods, make use of surrogate markers for growth, or are based on wholly new technologies. These new methodologies offer significant improvements in terms of the speed, accuracy, precision and specificity with which testing can be performed. However, in spite of the limitations of current culture methods, acceptance of new and potentially superior methods has only started to gain momentum within the pharmaceutical, biotechnology and medical device industries. We believe this continues to be due in part to a lack of clear guidance regarding the demonstration of their equivalence to existing methods acceptable to regulatory agencies and validation of the equipment associated with the new methods. In any case, many of these new rapid methods may have a role to play in other applications including missions in space where we want to know the impact of microorganisms on space travel, as well as what microorganisms might be waiting to be discovered.