8.1. Introductory remarks

Publisher Summary The microbiological methods described in Ph. Eur. III and USP 24 have remained almost the same for more than twenty years. Instrumental methods and new media developed during that period have not yet gained wide acceptance in the pharmaceutical industry. A number of reasons can be given to explain this reluctance to accept innovations. This chapter discusses that the types of organisms for which tests are provided in the pharmacopoeias may not be sufficient to assess the safety of a product, as other pathogenic micro-organisms may be present. Microbiological examination of pharmaceutical preparations is a risk assessment. Guidance is needed on how to perform such a risk assessment and on the types of “objectionable” micro-organisms that should be included in such a study.