Natural Products Insider

NOV-DEC 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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72 INSIDER November/December 2018 Contract laboratories provide a valuable and necessary service to the dietary supplement industry. Seldom is it the case that a brand owner, referred to as the own label distributor or product manufacturer, has an in-house laboratory that is equipped with the appropriate scientifi c expertise, facilities, instrumentation and quality systems necessary to conduct the wide variety of testing that is required in 21 CFR 111, cGMP (Current Good Manufacturing Practices) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. According to 21 CFR 111.70, specifi cations must be established for the identity, purity, strength, composition and limits of potential contaminants of all raw materials, packaging components, in-process materials and fi nished products; and then these specifi cations must be verifi ed to be met through testing per 21 CFR 111.75. FDA has also made it clear in numerous warning letters that, "Although a fi rm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement cGMP requirements." It is therefore critical that the contract laboratory (or more likely, laboratories) that are selected to conduct this testing are highly scrutinized for compliance to all the applicable subparts of 21 CFR 111. Scrutiny under the guise of a GMP environment requires a formal, controlled process with documentation thereof, and when it involves the assessment of regulatory compliance of a contracting partner this process is known as a "qualifi cation." The qualifi cation of a contract laboratory should be a multi-stepped, continuous process that assesses compliance through a documentation audit, onsite audit, ongoing monitoring activities via challenge testing, and periodic updates to the qualifi cation. Documentation Audit The documentation or "paper" audit is an assessment of key laboratory personnel, laboratory facilities, instrumentation and quality systems using a contract laboratory questionnaire that is completed by the laboratory and reviewed by the own label distributor or manufacturer. Questions should address all the regulatory requirements dictated in 21 CFR 111 and evidence to support the answers, such as procedures, documents and other records, must be provided. Emphasis should be made to ensure compliance with Subpart J—laboratory operations—which includes the evaluation of written procedures; laboratory facility information; equipment and instrumentation qualifi cation, calibration, and maintenance processes; critical laboratory control processes; management and use of scientifi cally valid test methods; and documentation systems. However, a thorough assessment of the laboratory organizational structure and key personnel education and experience, as well as personnel training program, is also critical. A fi nal area to examine is the investigatory system for deviations, out of specifi cation (OOS) results and corrective and preventive actions (CAPAs). Onsite Audit Onsite laboratory audits are essential to verify that the information provided on the questionnaire for the documentation audit are accurate and that the systems, policies, processes and test methods provided are being followed in practice. It is imperative that the auditor has expertise in laboratory operations, especially the type(s) of testing being performed at the contract laboratory. Own label distributors should hire an appropriate subject matter expert or use a laboratory consultant if an appropriate auditor is not available at the own label distributor. A thorough and detailed written summary of observations noted during the audit will then be prepared by the auditor. This is the document that will be used to assign necessary CAPAs and demonstrate laboratory compliance. Challenge Testing Challenge testing may be conducted to evaluate the overall performance of the contract laboratory, as well as provide an indirect assessment of the accuracy, precision, specifi city and ruggedness of the test methods. It can also be used as a tool to avoid "dry-labbing" or the falsifi cation of testing and/or test results. A good contract laboratory will not be offended by challenge testing. Various types of challenge testing options can be employed including inter-laboratory testing, the use of replicates, fortifi cation (spiked) samples and blind testing. For inter-laboratory testing, a single sample is portioned and submitted for testing to more than one contract laboratory simultaneously. The results obtained should be consistent with one another, given the test method variability. Replicate samples, preferably at least three, are submitted for testing to a single laboratory to evaluate the method precision and laboratory reproducibility. Tara Couch, Ph.D., is an analytical/organic chemist with more than 20 years of diverse laboratory and regulatory experience in academic, fi eld, contract and manufacturing environments. She is senior director of dietary supplement and tobacco services at EAS Consulting Group (easconsultinggroup.com). Ensuring a Contract Laboratory is in Compliance by Tara Lin Couch, Ph.D. Contract Labs Contract Lab Compliance at SupplySide West Learn more about how to ensure your contract laboratory is compliant from Tara Couch, Ph.D., during the "Effectively Partnering with a Contract Laboratory" Workshop on Wednesday, Nov. 7 at 1:30 p.m. at SupplySide West in Las Vegas. supplysideshow.com Scan Here

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