Natural Products Insider

JAN-FEB 2019

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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28 INSIDER January/February 2019 Supplement or natural product brand owners should be aware of FDA requirements under Title 21 of the Code of Federal Regulations (CFR), Part 117. It's the brand owner's responsibility to comply with FDA on all matters dealing with vendor selection, approval and auditing. A supply chain program must include using approved suppliers, determining appropriate supplier verifi cation activities, conducting supplier verifi cation activities and documenting supplier verifi cation activities. According to FDA, appropriate supplier verifi cation must include on-site audits, sampling and testing of the product, and review of the supplier's relevant food safety records. A contract manufacturer that doesn't allow a visit to its facility or that doesn't permit an audit (most excuses claim "secret stuff" is going on that doesn't allow for anyone in the facility) should be a big red fl ag. Brand owners are required by law to visit, approve and audit their manufacturers. Therefore, if the contract manufacturer is a GMP (good manufacturing practice)-certifi ed facility, it should welcome on-site visits. The following are some simple steps in preparing for an audit. First, an outline of what is being audited should be created; this can be supplied ahead of time to the manufacturer in an effort to save time Preparing for an Audit by Jeff Golini, Ph.D. on-site. An audit should take one full day, at most, if done properly. A CliffNotes-style book on FDA's 21 CFR part 111 can offer guidance as to what the manufacturer's responsibility is. These are the same books FDA auditors carry while doing on-site audits. The audit checklist should include a tour from start to fi nish, with the manufacturer explaining its fl ow process. Questions can help a brand owner to understand how a product fl ows from receiving to shipping. During this tour, the brand owner needs to pay close attention to cleanliness, organization, proper lighting and covers, whether employees are wearing the proper gear, and what procedure is in place when entering the facility. A notepad is useful to document fi ndings. Most manufacturers will not allow cameras inside the production area due to confi dentiality agreements with other brands that may be running during the time of the audit. The tour should also include a thorough look at a contract manufacturer's quality control (QC) laboratory. Brand owners should ask questions about the manufacturer's testing program and what is done to ensure products will be made according to specifi cations. After the tour, standard operating procedures (SOPs) should be reviewed. A table of contents can provide an overview of what SOPs a manufacturer has in place. Comparing the written SOPs to what was uncovered on the tour provides insight as to whether the manufacturer is doing things according to its SOPs. Speaking with the quality assurance (QA) manager, QC manager and production manager is critical to ensure they know government procedures. If the manufacturer's facility is clean and organized, and its employees have answered all questions openly, honestly and according to the CFR, it can receive a passing grade. It's critical to document the tour, design a vendor approval form to fi ll out and include all notes with this approval. These records should be saved and fi led in a safe place so they're accessible in the event of an FDA audit. Jeff Golini, Ph.D., is a multipatent holder, inven tor, author and scientist currently working at the helm of All American Pharmaceutical ( as CEO and excusive scientist. Golini has also published several studies and is the host of the national radio shows "Science for Humans" and "The EFX Sports Show" heard live on ESPN 910 Radio. Golini founded St. Anthony's Research & Education Institute in Billings, Montana. Contract Manufacturing: Best Practices

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