Researchers and manufacturers are focusing on the development of probiotic formulations because of consumers' awareness. By considering this, regulators are framing guidelines for ensuring the safety of live probiotics. Bacillus clausii with various formulations has a major share in the current market. We are Elmed Life Sciences, a leading probiotic manufacturer, manufacturing Bacillus clausii in different formulations. To ensure the quality and safety of our products, we adopted and modified test parameters like pH, Gram staining, spore staining, motility test, total viable count, heavy metals, arsenic, specific pathogens, and total yeast and mold count, validated and verified as per ICH Q2R2 guidelines for its intended purpose of use. All the test parameters met predefined validation criteria with respect to the coefficient of variation for intra-assay, inter-assay precision, limit of detection, recovery for accuracy, limit of quantification, robustness, coefficient of determination for linearity, range of the assay, and method specwificity for the specificity test, and reported the lower and upper limits of detection and quantification. We conclude that these parameters were suitable for testing and commercial release of the Bacillus clausii spores and its formulations.
