Testing Nutraceutical Products in the cGMP Era: Questions and Answers

Questions to Dr. Ruth Eden

With the full implementation of cGMP’s for dietary supplements, what are the changes that you have seen in microbiology testing and inquiries regarding how to comply with the regulations?

The implementation of cGMP for all manufacturers (large and small) of dietary supplements and Nutraceutical products means that all manufacturers must test their products for microbiology quality assurance and generate a Certificate of Analysis for each batch. The products need to be tested in accordance with the methods described in USP <2021> and <2022>. Products need to be tested for Total Aerobic Microbial Count, Total Combined Mold and Yeast, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organisms such as Salmonella, E. coli, and sometimes S. aureus). To do these tests companies either send product samples to contract laboratories for microbiological testing or test them internally. Many outside laboratories utilize BAM and AOAC methods that were never validated against the USP methodology for Dietary supplement products.

Any method that is different from the USP methodology (manual or equipment) used for microbiology testing needs to be validated prior to its use. The validation assures equivalency of the new method to the reference method. This means the new technique or device is giving us equivalent results to the USP methodology, the results are reproducible and can be trusted. USP <1223> Validation of Alternative Microbiological Methods describes the tests that need to be conducted.

Some manufactures were slow to implement the new regulations and the new methodology required for dietary supplement product testing. Others adopted methodologies from the food industry, without proper understanding of the difference between these methodologies and the USP methodologies. We get many inquiries from manufacturers that would like to save money, speed up time to microbiological results by internalizing their microbiological testing, while complying with the regulations.

What are some of the key issues surrounding microbiology testing that a manufacturer should consider when determining equipment and personnel needs for their laboratory?

Internal testing of products for microbiology gives the manufacturer much more control over the operation offering faster time to results, faster product release, and is more cost effective. Some manufacturers are hesitant to bring the microbiology testing in house for fear of the complexity of testing, the need for trained microbiologist, etc.

However, manufacturer share some common concerns when considering the internalization of microbiology testing: 1. Am I going to comply with FDA cGMP regulations? 2. How am I going to validate my testing? 3. Do I need to hire a microbiologist to internalize the testing? 4. Will this offer a return on my investment?

Also daunting is the need for a full validation package which is required for any method that deviates from the USP methodology. The validation package must properly document that the Installation Qualification (IQ) and Operational Qualification (OQ) were completed, to verify that the equipment was properly installed, calibrated and operational and that its performance are qualified. The Performance Qualification includes performance criteria such as: side-by-side comparison to the USP methodology, accuracy and precision, specificity, and range, limits of detection and quantification, along with ruggedness and robustness, reproducibility of the results, false positivity rate and false negative rate. Generating such data requires many resources.

BioLumix brings along a system that is fully validated during the system installation. With a simplified method such as the BioLumix System we can alleviate these fears and provide a simple cost effective method to test products for microbiology.

How does BioLumix plan to meet the changing requirements of dietary supplement manufacturers in implementing more precise, faster and cheaper microbiological testing in their laboratories?

BioLumix has developed a Rapid Microbiological Method that has been validated according to the FDA requirements. The validated BioLumix system is an alternative to the classic USP methodology. It is a streamlined testing system which is far less time consuming and requires less skilled technical personnel to operate. The BioLumix system offers a Certificate of Analysis for all relevant USP assays within just 48 hours. These include the FDA required tests such as total aerobic count, yeast and mold count, Bile-Tolerant-Gram -negative count, and objectionable organisms such as E. coli, S. aureus, and Salmonella. This means quarantine time for microbial testing is cut from 5-6 days to 24-48 hours for finished products, in-process and raw materials and environmental work surfaces.

Our system is fully validated during installation we perform the IQ, OQ and PQ required to fully validate the system in the customer location. We help write the appropriate SOPs, help generate the training records, and do not leave our customers until they are fully compliant.

The BioLumix testing system allows for faster sample preparation plus provides automated real-time communication, fast product release and early warning of contamination via USP microbiological testing. Because the BioLumix system is automated and its software generates the results, it is not necessary to have an employee dedicated solely to running the microbiology quality assurance tests. This makes the BioLumix system a cost-effective way for dietary supplement manufacturers to meet the new FDA cGMP requirements for microbiological testing.

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