This Guidelines is used to guide the quality control activities in pharmaceutical microbiology laboratories. Operations involving biosafety shall comply with relevant national, industrial, and local standards and regulations.

Microbiological testing results are affected by many factors. For example, microorganisms may be unevenly distributed within a sample; microbiological assays are subject to a considerable margin of error, etc. Therefore, in order to ensure the reliability of the testing results, pharmaceutical microbiology laboratories should use validated methods and strictly follow this Guidelines.

The Guidelines consists of the following aspects: personnel, media, reagents, microbiological cultures, environment, equipment, samples, test methods, disposal of hazardous waste, quality assurance and quality control, laboratory records, interpretation of assay results, test report, documentation, et al.