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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70 INSIDER September/October 2017 The fi nalization and recent enforcement of Food Safety Modernization Act (FSMA) requirements for Preventive Controls for Human Food and the Foreign Supplier Verifi cation Programs (FSVP) for Importers of Food for Humans accelerate the need for credible and accurate testing. It places greater accountability upon company compliance personnel and executive offi cials to ensure trusted third-party labs are selected, audited and validated (or qualifi ed). It also places a demand on the need for expertise of these outsourced labs with regard to testing methodologies, knowledge of testing standards, accuracy, precision, specifi city and ruggedness. Despite own-brand distributors being ultimately responsible for ensuring cGMPs (current good manufacturing practices) are followed in accordance with 21 CFR 111, contract manufacturers and contract laboratories share the responsibility for also ensuring compliance of their contract customers' products. For supplement brands to make the correct choices in securing an effective and successful partnership with credible third-party laboratories, several critical steps or "the four contract lab partnership rules" must be taken into consideration: selection, auditing and validation of a lab, as well as keen focus on reference standards and reagents. Selection of a lab: Always select more than one lab. This allows for the continuity of testing and avoids delays in product release, should one lab falter. Comparison of each lab in review of the regulations 21 CFR Part 111 Subpart J ("Production and Process Control System: Requirements for Laboratory Operations") shall provide the compliance basis for selection and prioritization. Other key factors include: common valid industry accreditations, level of training and expertise of technicians, up-to-date methods and technology, equipment condition and type, FDA audit history, cost of testing and location of the lab, and turnaround time. Auditing a lab: To assist with this aspect more easily, refer to regulations 21 CFR 111 Subpart F ("Production and Process Control System: Requirements for Quality Control"). Creating an audit checklist listing requirements of subpart F is the most thorough and concise, and least intimidating approach [for company offi cials] in handling this audit. A qualifi ed quality control (QC) analyst/offi cial should conduct the onsite audit ensuring to focus on the lab facility, methods, equipment, etc., relative to the product(s) to be tested. Disposition to choose the lab should be fi nalized in a quality agreement. Validating (qualifying) a lab: It is vital the data produced by the contract lab is accurate and credible. Therefore, it is critical the quality of the data used for decision-making purposes (e.g., certifi cate of analysis [CoA]) is assured. The following validation attributes are to be considered: lab equipment (IQ/OQ/PQ), data quality objectives, sample receipt handling and compendial methods (e.g. USP, AOAC and BAM). Periodic re-evaluation/re-qualifi cation should be conducted. Data quality and integrity is assured through adherence to the lab quality assurance (QA)/QC procedures and conformance to product specifi cations when samples are subject to testing by trained technicians. Reference standards and reagents: This is one of the most common and frequent issues of concern and confl ict for own-brand distributors and contract manufacturers. If partnerships with different contract labs exist, the standards used may not be the same, which could result in disparaging differences between test results of the same ingredients and/or fi nished products. Hence, the importance of conducting preliminary discussions between all parties involved. Challenges arise when the contract lab and in-house contract manufacturer's QC lab are in contentious dialogue. Add the contract customer or own-brand distributor, and the issue compounds. These situations can result in questionable data integrity, product launch or release delays, rejections or even broken partnerships. Third-party contract laboratories are becoming an integral partner in the own-brand and contract manufacturer partnership. Critical review and accountability of their role is crucial to assured product testing data and compliance. Choice is important, and following "The four contract lab partnership rules," can lead to a secure, effective and successful partnership for businesses. Heather Neves Duncan-Fairman is the Small Island Developing States (SIDS, sidsdock.org) DOCK Island Women Open Network (IWON) technical advisor. Comprised of 32 countries, the intergovernmental collaboration has all the rights and privileges of a United Nations organization. She is responsible for developing the herbal and botanical raw material and supplement industry across small islands in the Caribbean, Pacifi c, Africa and Indian Ocean regions. Contract Labs Contract Laboratory Partnerships: The Choice Factor and 'The 4 Rules' by Heather Neves Duncan-Fairman Learn more about contract labs from Heather Neves Duncan-Fairman during the "Selecting and Testing Your Contract Laboratory" Workshop on Tuesday, Sept. 26 at 9 a.m. at SupplySide West in Las Vegas. The session is underwritten by Alcami, Analytical Resource Laboratories, Eurofi ns, Micro Quality Labs and MIDI Labs. supplysideshow.com Scan Here Selecting and Testing Your Contract Laboratory at SupplySide West

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