With the recent mass breakout of fungal meningitis as the result of tainted steroid injections that were produced at the New England Compounding Center, many manufacturers are reflecting inwardly about their own products. The fact of the matter is with constant batch-to-batch testing using a number of analytical instruments including HPLC (high-performance liquid chromatography) analysis of your products, your company can avoid a contamination outbreak such as this and ensure that your product does not cause any harm to your customers or brands reputation in the future.
What Can Be Identified Through Testing?
There are a variety of uses for a chemical lab analysis even beyond identifying potential threats. Proper analytical testing can tell you what the base differences are between your product and that of your competitors, can inform you to any impurities that may exist within your product or raw materials, and can show new ways to either increase your products performance or possibly lower production costs.
Non-Government Regulated Manufacturing
One of the biggest controversies surrounding the New England Compounding Center is that they extended beyond the scope of their licensing. Compounding centers, unlike pharmaceutical manufacturers, are supposed to take existing medicinal units and combine them on a case-by-case basis for a patient’s specific needs. This is supposed to be triggered by a prescription from a doctor with the intention of distributing this compound to the one patient who the prescription was for.
This is not what was happening at the compounding center; instead they were acting as though they were a manufacturer and were providing thousands of units of various compounds to hospitals, doctors’ offices and surgical centers across the country.
These compounding centers do not answer to the U.S. Food and Drug Administration, but rather to their state pharmacy board. Had the center been following the regulations dictated by their license and had they been performing proper testing for contaminations, they may have been able to avoid this tragedy.
Why Your Company Needs Chemical Analysis
Perhaps you feel as though your company is not at risk for a contamination such as was seen with the meningitis outbreak, but that does not mean there is no use for testing.
As stated earlier, there are ways to find out the chemical differences between your product and that of your competition. This is a valuable tool because it can be used in product improvement, marketing campaigns and even new-product development.
But none of it would be possible without various testing such as HPLC analysis. Keeping your products safe and competitive will benefit your company in the long run.
Learn more at www.avomeen.com
Chuck Stevens is a part of an elite team of writers who have contributed to hundreds of blogs and news sites. Follow him @chuckstevens12.