For example, we expect test methods to identify the presence of organisms such as Pseudomonas cepacia or other Pseudomonas species that may be objectional or present a hazard to the user. Where pre-approval inspections are being conducted, compare the method being used against the one submitted in the application. Also verify that the laboratory has the equipment necessary to perform the tests and that the equipment was available and in good operating condition on the dates of critical testing. The USP states that an alternate method may be substituted for compendial tests, provided it has been properly validated as giving equivalent or better results. You may find that dehydrated media are being used for the preparation of media.
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.