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. Logs of such testing, along with the identification of the source of the sample, are also of value in the identification of potential microbial problems in processing. The utilization of automated systems for the identification of microorganisms is relatively common in the parenteral manufacturer where isolates from the environment, water systems, validation and people are routinely identified. Microbiologists in our Baltimore District are expert on the use of automated microbic analytical systems.