It has been over 20 years since the first Rapid Microbiology Methods were introduced. We sat down with our Director of New Products & Industry Affairs, David Jones, Ph.D., to talk with him about the year in review and what to expect for 2018.
You attended many of the fall meetings. What information and presentations did you find the most enlightening?
Jones – One presentation and one new working group stood out. Sven Deutchman’s keynote presentation at Pharmalab – “Challenges to QC Network,” focused on new manufacturing technologies that may cause challenges to the QC Micro lab. He highlighted the transition of manufacturing to smaller batches, single use manufacturing equipment, and the manufacture of personalized therapies. At PDA Micro in Bethesda, there was renewed interest in incubation profiles - single media/single temp - resulting in a new PDA working group and increased discussion on how Data Integrity impacts QC Micro. In addition, at both the US and EU conferences, representatives from all the regulatory bodies confirmed that they are receptive to Rapid Microbial Methods and have encouraged companies to discuss their validation protocols with them.
Since the release of the revised European Pharmacopeia 9.2 in 2017 and the revision of USP <1223> in 2015, could there be an interpretation that now the three compendia do not necessarily agree with each other as it relates to how RMMs should be validated? What is your take on this and how should companies proceed?
Jones – The compendia do differ slightly. USP <1123> and TR 33 have addressed the concept of an automated colony counter with a simplified validation; however, this is not specifically addressed in the European Pharmacopeia. Many European companies have successfully validated the Growth Direct™ as an automated compendial technology based on TR 33 and the two Pharmacopeia chapters. Several companies have now been successfully audited by German, Swiss, and FDA regulatory agencies. Validation of the automated compendial method requires only a subset of the alternative method validation parameters, specifically accuracy and precision. Companies are still required to perform method suitability and ensure that stressed cells have been included. Audit observations have focused on the validation rather than the technology. This has been apparent with regulatory observations citing lack of stressed cell testing, sample hold time testing, and equivalence to current method. When choosing an RMM, it is important that you that select a method that has strong validation support which will allow you to leverage best practices and help make your validation successful.
In conclusion, can you tell us what excites you the most about the future of rapid microbial methods in 2018?
Jones – I am excited by the broader uptake and use of RMM technologies and the implementation of automated systems like the Growth Direct to address data integrity compliance and reduce time to results. In addition, tracking and trending software like MODA EM linked to the Growth Direct allows for superior control of environmental quality and a more rapid response to contaminants in the manufacturing environment.
Rapid Micro Biosystems has many excellent guidance documents and an experienced staff available to facilitate your validation.
More information on the validation of the Growth Direct™ System can be found here