RMM Validation – The Role of Quality Assurance

For pharmaceutical manufacturers, growth-based RMM technologies allow for comprehensive, high-volume tests with streamlined validation. Still, it's not just quality control departments that must be involved in the validation of rapid microbial methods (RMM) technologies, and they're certainly not the only ones who have to contemplate the details of switching from the manual method to an automated process. The quality control department must partner closely with other areas, such as quality assurance, to successfully complete the validation.

In this final installment of our validation series, we’ll look at the role of quality assurance to the validation of the Growth Direct™ System.

Getting Involved Early

Of course, the first step in the implementation of an RMM technology is the actual selection of a system. In most cases, this decision comes down to the quality control (QC) department's business drivers. Even at this early stage in the process, the quality control team should be working closely with the quality assurance (QA) team to understand the requirements for a change in method of microbial testing, since the QA team is tasked with managing the documentation related to validating new equipment and ensuring its compliance with both internal policies and any regulatory requirements. With the Growth Direct™ System documentation is available for the IQ, OQ, PQ, TTR and method suitability testing and can be provided to quality assurance for review even before the installation of the Growth Direct™ System at the facility.

During the Validation Process

The quality control and quality assurance teams work as partners during the validation process. In the optimal scenario, the QA team reviews the documentation associated with a specific phase prior to the QC department’s generation of data, making sure the documentation is comprehensive and applicable. After the QC team completes the steps outlined in the documents, the QA team reviews the data generated to verify that the expected results were achieved. As mentioned above, the earlier the QA department can perform initial documentation reviews, the less likely delays will occur in the validation process. The reviews would happen for each of the steps listed as part of the validation process. In the case of the Growth Direct™ System, the steps are as follows:

• Installation and Operational Qualification (IOQ): Ensures that all systems are installed correctly and the equipment operates appropriately.
• Performance Qualification (PQ): Verifies the systems' performance compared to the compendial method using a variety of standard organisms.
• Method Suitability: Validates the new method against the specific product of interest. This step ensures that the product of interest does not exhibit any inherent characteristics that would interfere with the new method and that the new method produces results comparable to the traditional method.

Collaboration and Support From the Vendor

Rapid Micro Biosystems’ technical services team brings a wealth of validation experience and is available to work with QA during document reviews. In many instances customers choose to use the comprehensive validation documents available from Rapid Micro Biosystems which help simplify the QA review process. If you're looking to streamline your microbial quality control lab, don’t hesitate to contact Rapid Micro Biosystems today.