Debunking Rapid Method Myths at PDA

During the very popular Urban Myths session, I presented an overview of the myths associated with the inability of our industry to effectively implement rapid methods. Although a number of companies have successfully validated RMMs, they only represent a fraction of the industry that can benefit from using these alternative technologies. So what are the myths associated with RMMs? Here is a short list:

- Rapid methods are not accepted or understood by regulatory authorities, nor do they support QbD or PAT

- They will never replace pharmacopoeial tests

- There is little validation guidance

- RMMs offer no return on investment

- RMM use will result in exceeding specifications and action levels, which will translate to an increase in batch rejections

- Changing acceptance levels will not be allowed

During my presentation, I debunked each of these myths and many more, and provided support for rapid methods from global regulatory authorities in terms of validation, implementation and submissions. I also addressed where rapid methods can be used in contamination control programs, Quality by Design (QbD) and Process Analytical Technology (PAT) strategies. Much of what I discussed is already available for review in the Regulatory, Validation, and Return on Investment (ROI) sections at rapidmicromethods.com.

Briefly, the regulatory authorities not only accept and understand RMMs, but also have embraced and encouraged their use for a number of years. When formal changes to existing regulatory dossiers is required, both the FDA and EMA provide guidance and policies on how to accomplish this. And the Australian TGA and Japanese PMDA also support the implementation of RMMs as well.

Rapid methods can be used to support QbD and PAT strategies, including, but limited to, in-process bioburden testing, environmental monitoring, and process water and endotoxin analyses. Many companies have already validated RMMs as alternatives to compendial finished product release testing, such as USP and Ph. Eur. sterility testing (publications on the use of RMMs for finished product testing can be reviewed on our References page). And firms can and have realized significant cost savings and cost avoidances when implementing novel microbiological technologies. Finally, rapid methods can also support a comprehensive contamination control program, and when contamination arises, RMMs can be used as investigative tools, providing results much faster than traditional means.

In summary, most if not all RMM myths are not true, the regulatory authorities want to see RMMs implemented and encourage their use, RMMs are directly aligned with the future state of pharmaceutical manufacturing, QbD, PAT and continuous process and product improvement, there is validation guidance available, and the cost of implementation can be a good investment.