Drug Master File Submission

BioLumix DMF Submission for Rapid Microbiological System Accepted by FDA
DMF Submission accepted by FDA
BioLumix announced today that the US Food and Drug Administration (FDA) have accepted a BioLumix Drug Master File (DMF) entitled “Microbiological Rapid Method for the Detection and Enumeration of Microorganisms in Pharmaceutical Products”. The DMF provides specific technical and regulatory information to the FDA which allows companies planning to use the BioLumix Rapid Microbiological System to obtain regulatory approvals for prescription drugs.
The DMF can be referenced by drug manufacturers, reducing FDA review times and accelerating the regulatory approval process for use of the BioLumix System. In addition, USP <61> and <62> using a single testing platformOver the Counter (OTC) products can be tested in conjunction with the BioLumix Validation Package. The BioLumix DMF includes the information the FDA requires to assess alternative microbiological detection systems; such as, information about the technology, its accuracy, specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology.
“FDA actively encourages use of new technologies including rapid microbiology methods (RMM)” stated Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER. Newer microbiological methods can improve company’s’ quality of testing and result in significant financial savings. Such methods can reduce cycle times resulting in a leaner and more responsive supply chain.
The BioLumix System is extremely easy to operate, with its straightforward, streamlined testing design it offers rapid, accurate results leading to reduced material-holding time for faster product release. It offers simplified single-platform testing for all assays with a 48-hour Automated Certificate of Analysis, while avoiding any product interference.
ABOUT THE BioLumix DMF
In the DMF BioLumix shares specific technical and regulatory information with the FDA, including details about reagent composition, mode of action of reagents and growth media, and performance characteristics of its system. The FDA will be able to evaluate the use of the BioLumix system in pharmaceutical applications for rapid detection of microorganisms, when referenced by the customer.

A thorough scientific validation is a critical part of obtaining regulatory approval for a rapid microbiology method. There are two aspects of a new test method that should be addressed for approval and these were addressed in recent discussions with Dr. Bryan Riley (CDER, FDA, Silver Springs, MD):
1. Does the method work (in general). The general evaluation of a test method can be performed by the prospective user or literature references can be used to support the method. It is important to note that the user should not have to repeat the general method evaluation if the method is already in widespread use for a similar purpose.
2. Is the method appropriate for the specific sample(s) to be tested? The suitability of the test method for the proposed samples should be established by using the samples with the method to determine inhibition or enhancement.

In recent PDA meetings where regulatory expectations for RMM validation were discussed, FDA staff also recommended that the USP Chapterand/or PDA Technical Report #33 be used as a starting point for RMM validation activities; however, a firm may also develop their own validation strategy as long as it is scientifically sound and defendable.

Published in 2000, PDA Technical Report #33, “Evaluation, Validation and Implementation of New Microbiological Testing Methods” provides information on validation protocol design, testing and acceptance criteria, and installation, operational, and performance qualification strategies”. The USP informational chapter , “Validation of Alternative Microbiological Methods” provides guidance for the validation of methods for use as alternatives to official compendial microbiological methods. The chapter incorporates the analytical concepts from USP , “Validation of Compendial Methods” and relates them to alternative quantitative and qualitative microbiological systems.
For a new RMM, significant amount of data have to be generated to demonstrate that the new method is equivalent to the compendia method. The use of validation criteria as outlined in the USP and PDA TR#33 are best examined experimentally using standardized microorganism suspensions and samples spiked with known microorganism challenges. Read More …(in the next page)

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