Several alternative and rapid microbiological methods (ARMM) are now available to detect and enumerate microbiological contamination. Regulatory authorities are encouraging the biopharmaceutical industry to adopt these innovative technologies – but the path is sometimes clouded, and the absence of any best practice guidance has hindered their adoption.
This is why BioPhorum has written a framework for the evaluation, validation and implementation of alternative and rapid microbiological testing methods.
The paper addresses the need for a systematic and best practice approach to the assessment and deployment of ARMM. It also proposes a nine-step framework and common language that can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMM. These include improved monitoring, assurance and control of biopharmaceutical processes and manufacturing environments, and shortened cycles in the supply chain.
The barriers to adopting ARMM are both real and perceived. They include unclear drivers for application, lack of best practices for validation, capabilities advertised by vendors that do not fully meet the end-user’s specific needs and conjecture that regulators won’t support the methods.
The mission of the BioPhorum ARMM team is to remove those barriers to implementation by using its structured framework. This will guide users through the questions they need to ask to ensure a successful project:
- Evaluation, e.g. is it going to work? Is it going to meet our business needs?
- Validation, e.g. does it perform as well as or better than compendial methods?
- Implementation, e.g. how do we implement the method?
Using the paper’s structured approach means it will be easier for senior management to understand and thoroughly evaluate the business case of an ARMM proposal and allow them to filter out those that do not justify an investment.