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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74 INSIDER September/October 2017 A contract laboratory must be highly scrutinized by either the own-label distributor (OLD) or manufacturer to ensure the laboratory complies with the applicable subparts of 21 CFR 111 cGMP (current good manufacturing practices), as well as other regulations or statutory requirements. FDA has made this clear in numerous warning letters issued to industry members. Auditing a contract laboratory is the best way to evaluate and document that the laboratory has the necessary scientifi c expertise in terms of the personnel, facility, instrumentation, equipment and testing methodologies. An audit also is useful to confi rm a contract laboratory's compliance with FDA regulations. All lab personnel must possess the education, training or experence needed to perform their job function in accordance with 21 CFR 111.12(c). The same is true for assigned supervisors per 21 CFR 111.13(b). Responsibilities and activities for each job function or position should be described in a formal job description document, which should also indicate the required education, training and experience for the position. On-the-job training, classwork training and profi ciency training should be documented and provided in a personnel training record. The lab facility that performs the testing must be adequate per 21 CFR 111.310. This is stated in more detail in 21 CFR 111.20, where the regulation dictates the facility must be suitable in size, construction and design to facilitate maintenance, cleaning and sanitizing operations—there must be adequate space to prevent contamination and mix-ups. Another important type of scientifi c expertise in the laboratory is its instrumentation and equipment. Various instrumentation, particularly detection systems, can signifi cantly change the capability of the method of analysis, and the type used must be defi ned and appropriate for the sample. According to 21 CFR 111.27, all equipment must be of appropriate design, construction and workmanship to enable the equipment to be suitable for their intended use. This is generally accomplished using an equipment qualifi cation program. Documentation supporting the qualifi cation of several different types of equipment should be reviewed during the audit. Part of the review must include an assessment of any software or electronic operations being performed by the instrumentation. Equipment must then be calibrated and maintained at a frequency dictated by the manufacturer to maintain accuracy and precision per 21 CFR 111.27(b), and these activities must be documented in equipment logbooks. Multiple types of analysis techniques can be applied to perform a test, and many laboratories specialize in a certain type of technique. The test method selected must be appropriate for the sample and associated material or product specifi cation. Identifi cation tests can be qualitative, but only quantitative methods can be employed for strength (assay) testing. Contaminant testing must also be quantitative, and it is critical that these methods have the necessary detection and quantitation limits to achieve the material or product specifi cation limits. All controlled processes, including written procedures for the test method employed, must be developed and implemented in the lab as required in 21 CFR 111.325. There must be evidence these test methods are being conducted, as written, by lab personnel and that this is documented at the time of performance by the analyst or microbiologist. This documentation must be thorough and detailed, and include the performance of each point, step and stage of the method. Test methods used for the determination of whether a dietary supplement material or product has been met must be scientifi cally valid. FDA described a scientifi cally valid test method in the preamble to 21 CFR 111 as one that is accurate, precise and specifi c for its intended purpose, and consistently does what it is intended to do. Documentation that a method meets these criteria is accomplished from method validation studies for the particular sample matrix via experimentation, peer-reviewed literature, or compendial sources. Other critical laboratory-controlled processes to examine during an audit include out- of-specifi cation (OOS) investigations, deviations, and corrective and preventative actions. These situations are inevitable, and a strong quality system must be in place for handling them. Tara Lin Couch, Ph.D., is an analytical/organic chemist with over 25 years of diverse laboratory and regulatory experience in academic, fi eld, contract and manufacturing environments. As a consultant for dietary supplements at EAS Consulting Group (, Couch assists with the development, improvement and im plementation of quality systems that are scientifi cally sound, effi cient, practical and compliant with FDA regulations. She also performs mock FDA inspections, gap-analyses and contractor and laboratory audits. Couch provides GMP (good manufacturing practice) and laboratory trainings via seminar, webinar and on-site presentations. Auditing a Contract Laboratory by Tara Lin Couch, Ph.D. Contract Labs Learn more about auditing contract labs from Tara Couch 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. Scan Here Selecting and Testing Your Contract Laboratory at SupplySide West

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