BioSciences Quality Testing Forum

Spotlight

Electronic management of EM results in the micro lab: Critical considerations & financial justification

An appropriate microbiological Environmental Monitoring program should be established and used in production and lab facilities for sterile and non-sterile products. “In aseptic processing, one of the most important lab controls is the EM program” (FDA Guidance for ind.). Typical biopharma facilities may have several hundred or thousand environmental samples collected, processed on a daily basis. Most microbial EM programs generate a voluminous amount of data and require a large amount of time from the QC labs. Companies may consider acquiring data storage & management systems. This Spotlight addresses the critical points to look at when considering implementing a paperless EM data management solution.

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