Registration is now open for ASTM International’s Workshop on Microbiological Quality Levels, to be held May 7, 2024, in Philadelphia, PA. The event is sponsored by ASTM International’s manufacture of pharmaceutical and biopharmaceutical products committee (E55) and will be held in conjunction with the committee’s standards development meetings.

Manufacturing pharmaceutical and biopharmaceutical products has become increasingly complex, presenting a need for guidance on "how to quantify” an acceptable level of microbial contamination control used during the process.

To that end, the concept of a Microbiological Quality Level (MQL) has been proposed as a mechanism to determine the acceptable level of microbial contamination permitted during the manufacturing of a finished pharmaceutical, biopharmaceutical or combination product. This level is based on critical microbiological quality attributes and acceptance criteria for the product (i.e. specifications). When met, it delivers a high degree of confidence that the process step and/or product is acceptable.

This workshop will help professionals align and develop understanding of the different levels of product and process controls, their impact on microbiological quality, and the ability to determine a level of confidence in the output of a process. These exchanges will build the foundation and road map for creating an international industry consensus standard for microbiological quality level under ASTM committee E55.

Additional information is available from the technical co-chair, John Logar (Jlogar8@its.jnj.com).

For more information about these workshops, please visit: https://go.astm.org/microbiological-quality-levels.

Symposia Operations Contact: Tammy Schane tel+1.610.832.9522, symposia@astm.org

Release #11813

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