The FDA's Final Rule regarding dietary supplements has several important clauses regarding water quality management.

TOC Analysis and the FDA's Final Rule

Total organic carbon (TOC) analysis is a key means of measuring, and subsequently controlling, water quality for dietary supplement and nutraceutical manufacturing. The FDA's new Dietary Supplement Current Good Manufacturing Practices (cGMPS) "Final Rule" 21 CFR Part 111, contains several pertinent clauses relating to water quality management:

Water and Water Systems

The dietary supplement Final Rule states that minimum requirements must be met for water system validation, water quality, and water quality testing based on water classification (e.g., USP/EP Bulk Water). It also requires quality control personnel to conduct a raw material review and approve all components used to make the dietary supplement or nutraceutical product.

Cleaning Validation/Verification

The Final Rule requires adequate documentation, validation, and cleaning procedures that ensure specifications are met for the identity, purity, strength, and composition of dietary supplements or nutraceuticals. Limits must be established for those types of target compounds or contamination that may adulterate the finished product.

Method Validation

Minimum requirements must be established for using laboratory control processes and validation of methods related to establishing specifications, sampling, and testing or the nutritional supplements or nutraceutical components and products. The selection and use of testing and methods must be justified and well rationalized based on intended use.

Process Validation

Written procedures for most operations must be validated, including those steps that require specifications for any point, step, or stage in the process where control is necessary to ensure the quality of the dietary supplement.These process controls must be established in order to produce a product consistently and reliably each time.

Analytical Instrument Calibration and Maintenance

Analytical instruments used to test components or report data must meet minimum requirements for equipment calibration, maintenance and suitability for intended use.

Learn More

To learn more how the FDA's Final Rule on dietary supplements and how it may affect you, please contact our Nutraceutical Team.