Good practice includes the periodic challenge of prepared media with low levels of organisms. This includes USP indicator organisms as well as normal flora. These represent important considerations in any inspection and in the good management of a microbiology laboratory. While some manufacturers may be reluctant to provide tabulations, summaries, or printouts of microbiological test results, this data should be reviewed for the identification of potential microbial problems in processing. When summaries of this data are not available the inspection team is expected to review enough data to construct their own summary of the laboratory test results and quality control program.
Some laboratories utilize preprinted forms only for recording test data.
Some laboratories have also pointed out that the only way microbiological test data could be reviewed during inspections would be to review individual batch records. However, in most cases, preprinted forms are in multiple copies with a second or third copy in a central file. Some companies use log-books for recording data. These logbooks should also be reviewed. Additionally, many manufacturers are equipped with an automated microbial system for the identification of microorganisms.