In the months since we announced the 2013 availability of the Growth Direct™ System for multiple applications we have received a lot of positive feedback and many questions around the technology. One of the most common questions is, “Are regulators receptive to new RMM technologies and has this technology been reviewed by regulators?” Well, based on presentations delivered by regulators during conferences, the regulators consistently encourage companies looking into rapid methods to talk to them about validation plans. That openness emphasizes their receptivity for making changes from current, manual methods. A great example of their openness is the recent changes to CFR 610 rules around updates to sterility testing.
We have had the opportunity over the last few months to interact directly with regulators through facilitated global training courses for the IMB, FDA, and EU authorities. Through PIC/S (The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) organization we presented a session just last week to 25 regulators representing major countries in Europe (Germany, Sweden Spain, Belgium, Poland, Czech Republic) plus Indonesia, and Brazil.
After learning about our technology and its similarity to current compendial testing, the regulators provided feedback that our technology is the most straightforward of rapid methods from a validation perspective.
During our presentation, we went into detail describing the technology for our water, bioburden, environmental monitoring and sterility testing applications. We explained to the regulators that our technology breaks into two parts from validation perspective. The first component is the automated incubation and colony counting, and second is the growth based media used for the samples.
We explained what we saw as the key validation requirements for businesses around each application:
-- For water and bioburden testing, customers have already validated our method for routine use. Our method is exactly as performed in the current pharmacopeia
-- For environmental monitoring, the only difference from the traditional method is our use of a membrane for organism capture.
-- For sterility testing, the only impactful difference is the use of a different media
The approaches we described for the regulators for each application was confirmed to be acceptable.
-- The validation of the automation and colony counter required a demonstration of the accuracy of the system compared to the standard operator.
-- The validation of the growth-based component requires proof of equivalence of the membrane for the micro-organism capture for EM and growth using the new media vs. current media in sterility. Accuracy of microbial detection is required through microbial spike and recovery [e.g. B &F Testing for sterility} experiments with suitable replicate numbers to allow estimates of accuracy with suitable precision for statistical analysis.
If you are someone thinking about rapid methods, the information we have learned can give you the confidence in a few areas. First, you are taking on a technology that can be validated to regulatory requirements. Second, the validation technique is well known to your company’s QA group. Third, the validation process will be shorter than alternative RMM methods.
The regulatory agencies have consistently shown their willingness to work with companies through the process to help bring new technologies to microbial testing and the number of successful qualifications on sites increases every year with concomitant financial payback.