Nutraceutical Environmental Monitoring for FDA and GxP Compliance

In the US, the FDA regulates dietary supplements and nutraceutical products, which Health Canada defines as: “a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food. A nutraceutical is demonstrated to have a physiological benefit or provide protection against chronic disease.” However, the regulations are slightly different than those for other foods and drug products.

According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers are responsible for ensuring that a product is safe before it is marketed. Under the FDA Rule 21 CFR 111, companies that manufacture, process, or distribute nutraceuticals and supplements must follow the quality control guidance for Dietary Supplement Current Good Manufacturing Practices (cGMPS). In addition, reports on adverse events, including temperature or humidity excursions during processing, packing and shipping, must be recorded in a continuous and tamper-proof manner.

In addition to continuous monitoring, manufacturers and distributors need to perform validation/mapping studies of areas used to store and process nutraceutical products. According to the regulations for dietary supplements, validation is a necessary process by which manufacturers establish and demonstrate environmental compliance with the GMPs.

A comprehensive environmental validation program increases confidence in dietary supplement quality and ensures compliance during inspections. Sensors in Vaisala’s continuous monitoring system can be combined with the vLog software to perform accurate and reliable mapping studies. Truly wireless loggers, rather that thermocouple systems traditionally used in mapping studies, make the process simple and efficient. Study results are generated in secure, tamper-proof documents that aid in compliance with 21 CFR Part 11.

Monitoring in Dietary Supplement & Nutraceutical Processing Environments

Simple to install and easy to use, Vaisala’s continuous monitoring system gives you browser-based access to monitored points from any location with Internet access and provides 24/7 alarming via email/text or PC display. Users can receive and acknowledge alarms, generate and email reports and view real-time trend data from any remote location with Internet access. The ability to continuously monitor environments where multiple parameters are controlled protects valuable supplement components from degradation and ensures regulatory compliance.

The Vaisala monitoring system reduces the risk of lost product and GMP deviances with industry-best sensors and easy-to-use software. The system comprises viewLinc software and Vaisala’s reliable sensors for temperature, humidity, differential pressure, CO2 and other critical parameters.

The viewLinc software allows chambers to be managed via Web browser and send alarms for out-of-specification conditions. Users can run reports that are customizable, gap-free and compliant with 21 CFR Part 11, Annex 11 and other major regulatory standards. Designed for life science and GxP applications, the small size of the sensors, remote alarming capabilities, and tamper-proof reporting of the system is ideal for nutraceutical and dietary supplement manufacturing.