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Raising the bar for GMPs product testing

This is the second article in the series. Read the first.

So, here we are! We have our own specific Good Manufacturing Practices for the dietary-supplements industry. As the dust settles, companies — in particular, manufacturers and marketers — are wondering about their next steps. The FDA has stated that manufacturers and marketers, not raw-materials suppliers, are responsible for ensuring that finished products include all the correct raw materials as labelled, and are clean and free of contamination.

Experts appear to agree that these are the essential issues in the 'new world' — and hot buttons for enforcement. Any deficiency discovered in the finished product can cause the product to be subject to recall, with the marketing company and manufacturer possibly held responsible for paying recall costs and any associated penalties. In short, the stakes have been raised considerably.

In response, it seems critical that manufacturers 'raise the bar' regarding their testing programmes for raw materials and finished products. They need the means to completely test every raw material used in a product for identity, potency (if a claim is made), and cleanliness. In searching for and evaluating a contract manufacturer, a marketing company should pay close attention to areas such as: How are raw-materials samples drawn? How is the material quarantined during testing? Who will perform the testing — the manufacturer or a third-party testing facility? Who will pay for it? And, highly important, what testing methodology is being used and what validation of testing has been conducted to ensure accuracy?

Raw-materials test methods
In my estimation, every lot of every raw material, especially botanicals, should be thoroughly evaluated using the methods discussed below. I also recommend that correct micro levels are validated before using the raw material in production.

Organoleptic testing: Once the mainstay of many botanical companies, organoleptic testing ascertains that the incoming raw material looks, smells and tastes right. Because, in the old days, botanical companies purchased raw herbs in 'whole' form direct from the harvester, organoleptic evaluation was a reasonable first test. It was important that analysts were well versed in using their senses for correct botanical identification.

Currently, because most manufacturers purchase raw materials in a milled or powdered form, such sensory evaluations can be inaccurate, especially regarding the raw material's purity. Any contamination is all but impossible to see in a grounded and blended powder. Consequently, more scientific testing methods are now essential.

HPLC (high-performance liquid chromatography): A real asset in today's competitive environment, this methodology can accurately prove identity and even assay potency, or essential marker compounds, in the raw material. HPLC and, in some instances, GC (gas chromatograph — mass spectrum) will also show other compounds that might or might not be normally present in the raw material. Because many raw materials are similar, a well-trained analyst must use the above methodology correctly to ensure accuracy.

TLC (thin-layer chromatography): This method has recently gained greater acceptance and usage due to its increased capabilities to evaluate both identity and contamination issues. A sample of the raw material is 'plated' and evaluated under a special colour spectrum. Each raw material, especially a botanical compound, has a specific colour 'fingerprint' matched against a standard for that raw material. If the colours line up properly, then the identity is confirmed along with the essential compounds. TLC is gaining popularity because it is much faster than HPLC and GC, allowing raw materials to more quickly be evaluated and placed into production.

Micro Testing (microbiological): Due to the use of raw materials harvested from the wild and coming from offshore in large quantities, it is essential that a manufacturer 'micro test' each lot or shipment. A failure here can mean immediate problems. Salmonella, E.coli, Total Plate Count (TPC), and Pathogenic Evaluation are some of the buzzwords associated with this testing.

Finished-product evaluation
It is important that the manufacturer provide the marketer with some type of written confirmation of the finished product's final make-up based on results of the aforementioned testing methods. This documentation, referred to as a Certificate of Analysis or Certificate of Input, should be provided on each lot or batch. In addition, I believe that reverifying this certificate periodically is worth the expense, even though revalidation is not required by specific regulations.

Finally, in keeping with the 'raising the bar' theme of my message, I also believe it is essential from time to time to evaluate samples of finished product for 'micro' issues. This further ensures that the finished product is clean and void of unwanted microbiological content.

Brian Frisby is manager of business development for the Americas for Capsugel (and a certified quality auditor).
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