PDA Letter Article

Rapid Micro Methods Carry Potential

by Tony Cundell, PhD, Microbiological Consulting, and Michael Miller, PhD, Microbiology Consultants


For those who have worked to advance the implementation of modern microbiological methods for both in-process monitoring and finished product testing, the progress in this area has been disappointing.


Some of the reasons given for this slow progress include the perceived limitations of available technologies, uncertainties around regulatory acceptance of method validation and the inherent conservatism of the pharmaceutical industry.

In response to these challenges, PDA has organized a one-and-a-half-day workshop scheduled immediately after the close of the 14th Annual PDA Global Conference on Pharmaceutical Microbiology.

This workshop is markedly different from the usual rapid method podium presentations as invited speakers from regulatory agencies, standard-setting organizations and global subject matter experts will present their expectations and experience with method qualification and implementation. Experts will focus on paradigm shifts associated with moving away from colony forming units to signals that are not growth-based. Their positions will be supported with case studies covering the evaluation, validation and regulatory acceptance of novel rapid methods. Emphasis will be given to the requirements of global regulators and how various pharmaceutical companies evaluated new technologies in their manufacturing facilities, prepared regulatory submissions, and implemented the methods.

Learn more about the 2019 PDA Rapid Microbiological Methods Workshop.