Natural Products Insider

MAR-APR 2018

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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DIETARY SUPPLEMENT FORMUL ATION THE EASY WAY GENESIS R&D ® SUPPLEMENT FORMULATION & LABELING SOFTWARE • eliminates the need for spreadsheets • generates regulatory-compliant labels • integrates across the entire commercial value chain • tracks each phase of supplement development in one place • and much more Contact us today to start simplifying your workload. Supplement Formulation & Labeling sales@esha.com | www.esha.com | 503-585-6242 Contract Manufacturing targets for these actions fall mostly on contract manufacturers. Even in instances where activity from a business perspective is co-packing, the regulatory obligations found in GMPs remain, and the consequences are real and signifi cant. In the best-case scenario, the contract manufacturer recognizes the requirements and fulfi lls its regulatory obligations, with specifi c emphasis on performing the right tests and examinations of products as required. Should there be an inspection fi nding by FDA regarding the operation, prompt, effective response and implementation of commitments within the response are mandatory. The seriousness of consequences in time, money and potential continuation of business is real in the emerging normal of enforcement. This should be considered a positive in many ways since this enforcement activity raises awareness, at a minimum, and delivers the message that compliance is the only way to continue moving forward. The threat, in most instances, is self-infl icted. The solution is to review procedures, processes and activities performed, and confi rm the operation complies. Shortcuts to compliance are demonstrated in the most recent fi ndings of the inspections occurring. Third-party GMP certifi cation of the operation has little value when it comes to regulatory compliance. Confusion over obligations of the regulations and additionally imposed standards from these certifi cations do nothing to blunt the threat in this emerging normal. Contract manufacturers must be aware of all aspects of their operations, practices, testing and release of products, regardless of arrangements with their customers. No longer is enforcement less-than harmful. The solution lies in preventive techniques and a proactive quality mindset. Re-evaluate the procedures in place for the operation, regardless of the activities performed. Reassess the specifi cations established for each step where regulatory obligations require such specifi cations. Ensure appropriate testing against these specifi cations occurs and that components and products are controlled through proper release of the goods, once manufacturing is complete. As time passes, be assured that continually improving on the operations from a compliance perspective is mandatory as well. The consequences are not going to diminish and the level of detail in assessing compliance will only increase. As chief operating offi cer, Jim Lassiter oversees all consulting operations at Ingredient Identity (ingredientidentity.com). He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.

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