In-Depth Focus

QA/QC Microbiology/RMM In-Depth Focus 2022

Articles in this in-depth focus discuss how you can compare the accuracy of alternate and compendial micro methods and explore the use of RMM to enhance microbial control alongside compendial methods.

  • Testing non-inferiority for accuracy of quantitative microbiological methods
    Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
  • Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality
    New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock the full benefits of these new methods, they can be used to generate value. In this article, Pfizer colleagues Victoria Navarro, Joanny Salvas and Esther Bellón share an example that employs new technologies alongside the compendial methods to ensure quality within a process common across pharmaceutical plants: post-shutdown recovery and room release for manufacturing.