Many quality control professionals recognize that the need to modernize microbial detection methods is at an all-time high. However, some labs are still hesitant to do so because of the perceived difficulty behind implementing them. Establishing a project roadmap, understanding internal and external drivers, and meeting regulatory requirements continue to be pain points for QC labs. Furthermore, while many microbiologists understand the science behind alternative and rapid microbiological methods (ARMMs), they may not understand the business case for them.
Through 30 years of working in pharmaceutical microbiology in both manufacturing and R&D roles, Dr. Paul J. Newby gained experience in microbiological support for drug development, facility management, process control, registration and regulatory support, sterility assurance, and analytical method development and validation. He has compiled this eBook to help share his knowledge and assist with the successful implementation and uptake of new ARMMs into the pharmaceutical industry. This document outlines the process stages as well as the technical, business, and data integrity issues to be addressed in implementing ARMM technologies for use in the development, in-process control, and commercial release of drug products.
