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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68 INSIDER September/October 2017 making sure they are compliant to the new regulations. INSIDER: What are the top items a supplement brand/contract manufacturer should ask a potential contract lab it partners with? Eberhart: First, ask whether the lab is an FDA Registered independent contract testing laboratory. Before hiring a lab, conduct an audit and ask for previous FDA audit reports. Ask if the laboratory is qualifi ed to conduct the analysis or service. Check for accreditation from such organizations as the International Association of Analytical Communities, the American Society for Testing and Materials and others. Third, ask about the laboratory's lead-time requirements. Blakemore: A brand should partner with a lab that offers its required testing on its scope of accreditation. A method on the 17025:2005 scope of accreditation shows that it has profi ciency data to support the accuracy of the results. Make sure the method the contract lab runs is appropriate for the testing need. Ask questions to determine the contract lab's review process for out-of-specifi cation (OOS) results before they are released. John Atwater, Ph.D., senior director, USP Verifi cation P rograms: A supplement brand/ contract manufacturer should ask the contract lab for 1 information about its area of specialty and what accreditations it has, e.g., ISO 17025 for specifi c tests, 2 information about its key staff's level of education, skill and experience; and 3 information about its facility, list of analytical equipment, and list of laboratory standard operating procedures (SOPs) and test procedures. Teller: It is important to investigate the lab's ability to communicate effi ciently and timely. A quality lab will have rapid, honest communications with its clients. It is also important to understand its quality systems and how it validates its methodologies. A quality lab will seek for better, more effi cient and cost-effective ways to validate products, which requires a commitment to fl exibility and growth, without compromising integrity. Johnson: When vetting a contract lab, among the most important things to ask are: 1 How does the lab interpret "scientifi cally valid," specifi cally, how are testing methods selected and determined to be fi t for purpose? 2 How are reference standards used for qualitative and quantitative testing? 3 Does the contract lab provide method transparency and willingness to resolve confl icting data? INSIDER: What are the top three things a supplement brand/contract manufacturer should look for during an onsite audit? Couch: Five general areas should be evaluated, which are dictated in 21 CFR Subpart J: 21 CFR 111.303 (establish and follow written procedures for laboratory operations), 21 CFR 111.310 (use adequate laboratory facilities to perform testing and examinations), 21 CFR 111.315 (control processes must be reviewed and approved by quality control personnel), 21 CFR 111.320 (use appropriate scientifi cally valid test methods), and 21 CFR 111.325 (2)(i)(ii) (document testing and examinations, and include all test results). Atwater: A supplement brand/contract manufacturer should ensure that the staff have the appropriate technical education, skills and training to enable them to perform the testing; that all the testing is performed in a competent and workman like manner; and that the lab has the appropriate instrumentation and facilities, and that they are properly maintained and calibrated. Clifford E. Poindexter III, laboratory manager, MIDI Labs Inc.: Is laboratory equipment validated and calibrated? Is there a quality system and a quality manual? Is there document control? Is there a suffi cient CAPA (corrective and preventive action) system? Aylozyan: Brands should check basic information such as SOPs, test methods, micro/analytical procedures and most importantly, raw data. Review a result and ask for chromatographs to ensure the results are reported scientifi cally. The auditor will be able to review the receiving process, the testing process, the data calculation process and the release process. INSIDER: How can a supplement brand/contract manufacturer ensure that its contract lab uses assays that are fi t for purpose? Heather Neves Duncan Fairman, technical advisor for the Small Island Developin g States (SIDS) DOCK Island Women Open Network (IWON): This assurance can only come through early meaningful discussion with the contract lab concerning the brand product/contract product type and ingredient contents. Early discussion about the product formulation/ ingredients is crucial to the contract lab understanding and determining whether it has the suitable methods and capability to test the product(s). Johnson: Communicate with the contract lab! Selecting a fi t-for-purpose method is specifi cation driven and often depends on knowing critical details about the sample to be tested. A brand should ensure it talks with its lab about the nature of the sample, how it was produced, what method was used to set the spec, formulation details, purpose of the testing requested, etc. If a contract manufacturer does not provide the right info, the contract lab cannot always select proper test methods. Couch: Fit-for-purpose assays would be designated as scientifi cally valid test methods per 21 CFR 111.75(h)(1) and 111.320(b). FDA describes a scientifi cally valid test method as one that is accurate, precise, specifi c for its intended use, and consistently does what it is intended to do (rugged) in the preamble to the regulation. This must be documented with scientifi c experiments and/or a compendial and peer-reviewed documentation review for the associated sample matrix. Stassi: The precision and accuracy should be a signifi cant factor in demonstrating that the method performance is acceptable for the type(s) of samples that are being analyzed. The laboratory must be forthcoming about the method performance data with a validation report and/or any corresponding supporting data. These should not be confi dential documents, and a brand should have full access to these records when needed. In the absence of specifi c data or for new matrices being tested, the laboratory should design and conduct a product- specifi c validation when needed. Contract Labs

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