A Future of MQL and Managing Risk Release - 12 de septiembre de 2024 - TecnoWebinars.com

The concept of a Microbiological Quality Level (MQL) has been proposed as a method for determining the acceptable level of microbial contamination permitted during the manufacturing of or on a finished pharmaceutical, biopharmaceutical or combination product. The Kilmer RMM and PAT collaboration teams, along with ASTM Committee E55, have been exploring the use of Microbiology Quality Level (MQL) as means to enabling this future and this webinar will introduce and eexplore this concept as a means of determining probability/quantification of microbial risk for each step and its contribution to the final product as a mechanism to differentiate the microbiological quality of finished product.