Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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60 INSIDER September/October 2017 of necessary testing. Simple math will dictate whether the lab has the capacity to do what's needed, so a brand owner should review the lab's daily workload and confi rm this information, including the chemist's ability to interpret the results. Contaminants testing: Typical contaminants are heavy metals and microbiological. However, more botanicals and botanical extracts are being adulterated. If the contract manufacturer does identity testing using FTNIR, HPTLC or HPLC/UPLC, it should be able to identify adulteration of the raw material. Heavy metals and microbiological contaminant testing are routine tests and can be done by an in-house lab or outsourced. These are usually run concurrent with the identity and potency tests to save time. Potency testing: This is a cGMP test requirement if potency of the raw material is part of the specifi cation. For example, if a brand is using a Rhodiola rosea extract and making a rosavins content claim on the product label, then the contract manufacturer will be testing for the rosavins content in the raw material as a key identity marker. In most cases, this quantifying of active or biomarker compounds is usually performed using a HPLC/UPLC method. Finished product testing: In this case, the contract manufacturer cannot rely on anyone else's data or information. It must either perform the test or contract it to a third-party lab. The lab techniques are much the same as those used for the potency testing, i.e., HPLC/UPLC, inductively coupled plasma mass spectrometry (ICP-MS) for mineral testing, which is same equipment used to identify heavy metal contamination. Cautions One issue that has been on the radar in the industry is "dry labbing." Contract manufacturers with an in-house lab that is under-staffed or does not offer adequate capability or certain third-party labs will sometimes "dry lab" results, which is creating numbers to push the items through the lab and out the door. This causes issues with cGMP compliance, and risks the brand owner's good name and industry standing. Material and product specifi cations and testing for such is a cGMP requirement that cannot be shirked or ignored. Any contract manufacturer that cuts corners to reduce delivery times or save money by offering to overlook these requirements isn't doing a brand any favors. Correct, robust testing done by the contract manufacturer and/or qualifi ed third-party lab helps ensure the viability of the product and safety of your consumers. Michael Finamore is CEO of Gemini Pharmaceuticals Inc. (, a contract manufacturer of both dietary supplements and over-the-counter (OTC) pharmaceuticals for more than 30 years. All Gemini production is carried out in a pharmaceutical cGMP (current good manufacturing practice) environment. • 410-754-8141 • Visit us at SupplySide West Booth# SS151 Fulfillment Service Inc. SISK Scan for more details & contact us today. • • NSF cGMP COMPLIANCE • TEMPERATURE & HUMIDITY CONTROL • RETURNS MANAGEMENT • HIGH VOLUME ORDER CAPACITY • SAME DAY ORDER FULFILLMENT • LOT # AND EXPIRATION DATE CONTROL Contract Manufacturing: Ingredient Sourcing

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